Risk-Driven FDA Readiness Focused on High-Exposure Systems and Processes
FDA inspections often focus attention on areas of highest regulatory and patient safety risk. We frequently see Life Sciences organizations […]
FDA Inspection Readiness
Mock FDA Inspections That Replicate Real-World Questions, Pressure, and Pace
Passing internal audits does not always translate to inspection success. We often see Life Sciences organizations perform well on paper
Inspection Readiness That Tests Data Integrity, Documentation, and Team Behavior
Regulatory inspections today go far beyond verifying that procedures exist. We often see Life Sciences organizations pass internal audits yet
Turning FDA Inspection Anxiety Into Confident, Controlled Execution
For many Life Sciences organizations, FDA inspections are a source of significant stress. Teams may worry about unexpected questions, gaps
Applying CSV Principles to Cloud-Based, SaaS, and Agile Technologies
As Life sciences organizations increasingly adopt cloud-based, SaaS, and agile technologies, ensuring regulatory compliance and system validation becomes more complex.
Top 10 Life Sciences Consulting Firms Driving Biotech and Pharma Innovation
The Life sciences and Biotech sectors are evolving rapidly, with organizations striving to bring innovative therapies, diagnostics, and medical devices
QMS Readiness for FDA Inspections, Partner Audits, and Due Diligence
BioBoston Consulting | Audit-Driven QMS Readiness for Life Sciences Quality Management Systems are tested not only by regulators but also
Mock FDA Inspections Led by Former FDA Investigators and Industry Experts
BioBoston Consulting | Inspection-Ready Audits and Proactive Regulatory Preparation FDA inspections can be high-stakes and stressful, particularly when teams are
FDA Inspection Readiness: From Compliance Obligation to Strategic Advantage
Most organizations believe they are inspection ready until inspectors start asking questions. We often see capable life sciences teams caught off guard
When an FDA Inspection Reveals the Unexpected: Why Inspection Readiness Can’t Wait
Imagine this scenario: A mid-size Pharmaceutical manufacturer had been operating with what they believed was a “strong enough” quality system. Their last FDA inspection was
FDA Inspection Readiness: Transforming Compliance into a Strategic Advantage
Are You Confident Your Organization Could Withstand an FDA Inspection? Even well-prepared life sciences organizations can face surprises during FDA
Top 10 Life Sciences, Biotech, and Pharmaceutical Consulting Firms of 2025
Many teams across Biotech, Pharma, and MedTech tell us they rely on consulting partners to navigate pressure points in development, compliance, and commercialization. We
Why Strong QA Systems Are Now a Competitive Advantage for Life Science Companies
Many life sciences organizations discover that quality issues surface long before an inspection. These issues such as gaps in documentation,
Top 10 Consulting Firms Shaping Growth Across Life Sciences, Biotech & Pharma in 2025
One Stop Solution for Life Sciences Many life sciences organizations have ambitious plans such as new programs to launch, new
The 10 Market Leaders Mastering FDA Inspection-Readiness
The 10 Market Leaders Mastering FDA Inspection-Readiness When we review inspection outcomes across the industry, a clear pattern appears: the
Quality Assurance Reinvented: How BioBoston Consulting Elevates Compliance in Life Sciences
Quality teams carry a heavy burden today. We often meet organizations where SOPs have grown in silos, documentation has lost
Is Your QMS Holding You Back? Here’s How to Build a Strong, Inspection-Ready System
When we work with new clients, a familiar pattern often emerges. Teams are committed and capable, but their Quality Management
From Data Integrity to Documentation: Your Complete Roadmap to Compliance Excellence
In many of the organizations we support, the first signs of compliance stress appear in fragmented documentation, incomplete audit trails,
Achieving End-to-End Compliance: BioBoston Consulting’s Blueprint for Audit-Ready Operations
Many of the clients we support come to us after experiencing inconsistent documentation, data-integrity findings, or challenging interactions with regulators.
FDA Inspection Readiness: Ensuring Compliance, Quality & Confidence
Are You Truly Prepared for an FDA Inspection? Could gaps in your documentation or processes cause delays in FDA approval?
10 Leading Life Sciences Companies Accelerating Innovation from Pre-Clinical to Commercial Success
Shaping the Future of the Life Sciences Industry The global life sciences ecosystem is evolving faster than ever before. As
FDA Inspection Readiness: Transforming Compliance into a Competitive Weapon
In Life sciences, an FDA inspection is more than a regulatory milestone it is a defining moment. It reveals the strength of your
10 Leading Life Sciences Companies Accelerating Innovation from Pre-Clinical to Commercial Success
Shaping the Future of the Life Sciences Industry The global life sciences sector is advancing at an unprecedented pace, as
Inspection Readiness for FDA, EMA, and Global Regulatory Agencies
Proactive Compliance Across Global Regulatory Agencies For Pharmaceutical, Biotechnology, and Medical device companies, inspections from the FDA, EMA, and other global regulatory agencies are critical checkpoints
How to Prepare for an FDA Inspection: Expert Consulting by BioBoston
Ensuring Regulatory Compliance with FDA Inspection Readiness For Pharmaceutical, Biotechnology, and Medical device companies, an FDA inspection is a critical event that validates compliance with GxP and cGMP regulations. Being
FDA Inspection Readiness Simplified — Proactive Solutions
Simplifying Compliance in a Complex Regulatory Landscape In the highly regulated Life sciences industry, achieving FDA inspection readiness can feel overwhelming. Pharmaceutical, Biotech, and Medical device
Achieve FDA Inspection Readiness with Confidence
Ensuring Regulatory Excellence in Life Sciences For Pharmaceutical, Biotechnology, and Medical device companies, FDA inspection readiness is not just about passing an audit, it is about demonstrating a strong culture
10 Leading Life Sciences Companies Accelerating Innovation from Pre-Clinical to Commercial Success
Shaping the Future of the Life Sciences Industry The global life sciences landscape is advancing at a record pace, with
FDA Inspection Readiness: Ensuring Compliance and Confidence for Life Sciences
Are You Truly Prepared for an FDA Inspection? Could gaps in your documentation or processes cause delays in FDA approval?
FDA Inspection Readiness for New Drug and Biologic Submissions
Ensuring Compliance for Regulatory Approvals The submission of new drug applications (NDAs) and biologic license applications (BLAs) is a critical step for Pharmaceutical
FDA Inspection Readiness for Clinical Trial Sponsors and CROs
Ensuring Compliance in Clinical Trials In the Pharmaceutical and Biotechnology industries, clinical trial sponsors and Contract Research Organizations (CROs) are held to strict regulatory
Risk-Based Internal Audits for GxP-Regulated Environments
Proactive Compliance in a GxP-Regulated World In today’s life sciences industry, compliance is more than a regulatory requirement; it is a foundation
Inspection-Ready Audit Strategies for Clinical and Manufacturing Operations
Building a Culture of Continuous Audit Readiness In the Life sciences industry, regulatory inspections are pivotal checkpoints that validate compliance, data integrity, and patient safety.
How to Prepare for Regulatory Audits: Internal and Vendor Oversight
Staying Ahead in a Regulated Industry In the Life sciences sector, regulatory audits are more than just checkpoints; they are critical milestones that reflect
FDA Inspection Readiness: Transforming Compliance into Strategic Advantage
In the Life sciences industry, FDA inspections are pivotal events that define your organization’s credibility, compliance, and operational maturity. FDA inspection readiness is more
Top Strategies for FDA Inspection Readiness in Pharma & Biotech
Why FDA Inspection Readiness Is Essential for Pharma and Biotech Companies In the pharmaceutical and biotechnology industries, maintaining compliance with FDA regulations is critical to ensure product safety,
FDA Inspection Readiness: How Biotech Companies Can Ensure Compliance and Success
Understanding FDA Inspections in the Biotech Industry For biotechnology and life sciences companies, FDA inspections are a critical component of regulatory compliance. These inspections
GxP Compliance and FDA Inspection Readiness: What You Need to Know
Understanding GxP and Its Role in FDA Compliance In the life sciences, pharmaceutical, and biotech industries, GxP compliance serves as the foundation for maintaining product quality, patient
Achieving Audit-Ready Operations: FDA Inspection Readiness Tips
Strengthen Compliance, Minimize Risk, and Build Audit Confidence with BioBoston Consulting In the highly regulated world of Pharmaceuticals, Biotech, and Medical devices, achieving audit-ready operations is
FDA Inspection Readiness: Turning Compliance into Competitive Advantage
In the Life sciences industry, FDA inspections are pivotal moments that define your organization’s credibility, compliance, and operational maturity. Being inspection ready is
Mock FDA Audits and Gap Assessments for Life Sciences Firms
For life sciences organizations, FDA inspections are high-stakes events that test every aspect of operations, from documentation and processes to
How to Prepare for FDA Pre-Approval Inspections: Expert Guidance
For pharmaceutical and biopharma companies, FDA Pre-Approval Inspections (PAIs) are critical steps in bringing new products to market. These inspections
FDA Inspection Risk Mitigation and CAPA Planning Services
For life sciences and biopharma organizations, FDA inspections are critical milestones that test compliance with Good Manufacturing Practices (GMP). Without
FDA Inspection Readiness Roadmap: From Planning to Execution
For life sciences and biopharma companies, being prepared for an FDA inspection is essential to ensure GMP compliance and avoid
FDA Inspection Checklist for Pharmaceutical Manufacturers
In the pharmaceutical industry, FDA inspections are crucial to ensure that manufacturing facilities, processes, and products comply with regulatory standards.
FDA Form 483 Prevention Strategies for Biopharma Innovators
For biopharma innovators, receiving an FDA Form 483 can be a significant regulatory challenge. Form 483 observations highlight potential GMP
FDA Inspection Readiness: Empowering Life Sciences Companies for Regulatory Excellence
In the life sciences industry, FDA inspections are not just regulatory milestones—they’re crucial moments that define your organization’s compliance, quality
Your FDA Inspection Playbook: Preparing Teams, Systems, and Documentation for Success
Master Every FDA Inspection with Confidence For biotech, pharmaceutical, and life sciences organizations, FDA inspections are high-stakes events that test
Top FDA Inspection Readiness Challenges and How BioBoston Consulting Helps You Overcome Them
Navigating the Complexities of FDA Compliance For biotech, pharmaceutical, and life sciences organizations, achieving FDA inspection readiness is a complex,
Is Your Organization FDA-Ready? BioBoston’s Proven Approach to Inspection Preparation
Ensuring Compliance, Confidence, and Readiness for Every FDA Inspection Preparing for an FDA inspection can be a defining moment for
Inspection Readiness for the Future: Aligning People, Processes, and Technology with FDA Standards
Future-Proof Your Organization for FDA Compliance In today’s rapidly evolving biotech and pharmaceutical landscape, FDA inspections demand more than reactive
Driving Inspection Readiness Excellence: BioBoston’s Expertise in FDA Regulatory Preparation
Achieve Regulatory Confidence with BioBoston Consulting For biotech, pharmaceutical, and life sciences organizations, FDA inspections are pivotal events that test
Be Proactive, Not Reactive: Building FDA Inspection Readiness into Everyday Operations
Transforming Compliance from Event-Driven to Continuous Excellence For biotech, pharmaceutical, and life sciences organizations, FDA inspections can be high-pressure events.
Be Inspection-Ready with BioBoston Consulting’s FDA Inspection Readiness Services
Preparing for an FDA inspection is a critical business moment for life sciences organizations. BioBoston Consulting delivers focused FDA Inspection
How to Build a Risk-Based Audit Program for Life Sciences
Your One Stop Solution for Life Sciences In the life sciences industry, audits are essential for ensuring regulatory compliance, product
How to Audit for 21 CFR Part 11 Compliance in Digital Systems
Your One Stop Solution for Life Sciences In the biopharma and biotech industries, ensuring 21 CFR Part 11 compliance in
Audit Readiness: How to Prepare for Internal and External Inspections
Your One Stop Solution for Life Sciences In the biopharmaceutical and biotech industries, being prepared for internal and external audits
Audit Fatigue in Pharma: How to Streamline Internal and Supplier Reviews
Your One Stop Solution for Life Sciences In the pharmaceutical and biotech industries, organizations often conduct frequent internal and supplier
Data Integrity in FDA Inspections: Why It’s Critical for Life Sciences Compliance
One Stop Solution for Life Sciences 🔍 Why Data Integrity Is a Cornerstone of FDA Compliance In the life sciences
Navigating FDA Inspection Types: Understanding PAI, GMP & Surveillance Audits for Life Sciences Compliance
One Stop Solution for Life Sciences 🔍 Demystifying FDA Inspection Types in Life Sciences For pharmaceutical, biotech, and medical device
FDA Inspection Readiness: Core Elements of Documentation, Training & Compliance for Life Sciences
One Stop Solution for Life Sciences 🔍 What Is FDA Inspection Readiness and Why It Matters For pharmaceutical, biotech, and
FDA Inspection Readiness for Global Manufacturers: Ensuring Compliance When Exporting to the U.S.
One Stop Solution for Life Sciences 🌍 Why Global Manufacturers Must Prioritize FDA Inspection Readiness For international pharmaceutical, biotech, and
FDA Inspection Readiness Checklist: Key Compliance Essentials for Life Sciences Companies
One Stop Solution for Life Sciences 🔍 Why FDA Inspection Readiness Is Non-Negotiable For pharmaceutical, biotech, and medical device manufacturers,
Mastering FDA Inspection Readiness: Best Practices & Benefits of Mock FDA Audits for Life Sciences
One Stop Solution for Life Sciences 🔍 Why Mock FDA Inspections Are Critical for Compliance In the life sciences industry,
Quality Assurance and Regulatory Compliance: The Cornerstone of Trust in Life Sciences
One Stop Solution for Life Sciences 🧬 What Is Quality Assurance and Regulatory Compliance? Quality Assurance (QA) and Regulatory Compliance
FDA Inspection Readiness: Your Compliance Shield in the Life Sciences Industry
One Stop Solution for Life Sciences 🏛️ What Is FDA Inspection Readiness? FDA Inspection Readiness is a proactive, strategic approach
Avoiding FDA 483s: Common Biotech Pitfalls and How to Stay Compliant
In the biotech industry, few things disrupt operations and damage reputations like receiving an FDA Form 483. These inspectional observations
Your FDA Inspection Survival Kit: What Every Biotech Team Needs to Know
When the FDA arrives for an inspection, biotech companies must be ready to demonstrate compliance, transparency, and control. Success hinges
FDA Inspection Readiness: A Startup’s Roadmap to Compliance Success
For biotech startups, securing FDA approval is a major milestone but passing an FDA inspection is often the first real
FDA Inspection Readiness: Why It Matters and How BioBoston Consulting Can Help
One Stop Solution for Life Sciences ✅ What Is FDA Inspection Readiness? FDA Inspection Readiness refers to the strategic preparation
Regulatory Compliance Simplified: FDA Inspection Readiness for Life Sciences
Introduction: Making Compliance Manageable In the life sciences industry, maintaining regulatory compliance and achieving FDA inspection readiness can be challenging.
Partner with BioBoston Consulting to Achieve Seamless FDA Inspection Readiness
Introduction: Preparing for FDA Inspections with Confidence FDA inspections are a critical component of regulatory oversight for pharmaceuticals, biologics, and
Mastering FDA Inspections with BioBoston Consulting Expertise
Introduction: Confidently Navigate FDA Inspections In the life sciences industry, FDA inspections are a critical component of regulatory oversight. Successfully
From Documentation to Processes: Complete FDA Inspection Readiness
Introduction: Ensuring Compliance Across Every Level In the life sciences sector, achieving FDA inspection readiness requires more than just proper
FDA Inspection Readiness Checklist: Are You Fully Prepared?
Introduction: Proactive Preparation is Key In the life sciences industry, FDA inspection readiness is critical to maintain compliance, protect product
Avoid FDA Surprises: Proactive Inspection Readiness Strategies
Introduction: Staying Ahead in Life Sciences Compliance In the life sciences industry, unexpected FDA inspections can disrupt operations and delay
Achieving FDA Compliance and Inspection Readiness: Best Practices
Introduction: Ensuring Compliance in Life Sciences In the highly regulated life sciences sector, achieving FDA compliance and maintaining inspection readiness
Internal & Supplier Audits: Ensuring Quality, Compliance & Trust
One Stop Solution for Life Sciences In life sciences—whether pharmaceuticals, biotech, medical devices, or diagnostics—maintaining product safety, compliance, and operational
FDA Inspection Readiness: Be Prepared, Be Compliant
One Stop Solution for Life Sciences In life sciences—pharmaceuticals, biotech, medical devices, diagnostics—FDA (Food and Drug Administration) inspections are central
Top Regulatory Compliance Challenges in Life Sciences
Understanding Regulatory Compliance in Pharma and Biotech Navigating the life sciences industry requires strict adherence to regulatory requirements. Pharmaceutical, biotechnology,
Global Harmonization of QA Standards: FDA, EMA, ICH, and MHRA
Why Harmonization Matters in Life Sciences In the pharmaceutical, biotechnology, and medical device sectors, companies operate across global markets. Navigating
The Role of Risk-Based Validation in Modern CSV Approaches
Evolving CSV Practices in Life Sciences In the life sciences sector, Computer System Validation (CSV) is essential for ensuring compliance,
How to Prepare for FDA Inspections with Strong CSV Documentation
Why CSV Documentation Matters for FDA Inspections In today’s highly regulated life sciences industry, Computer System Validation (CSV) is not
Electronic Records and Part 11 Compliance Through CSV
Why Part 11 Compliance Matters for Life Sciences In the life sciences industry, electronic records and signatures are central to
CSV in Manufacturing: Complying with FDA cGMP Requirements
Why CSV Matters in Manufacturing In pharmaceutical, biotech, and medical device industries, Computer System Validation (CSV) is critical for ensuring
CSV for Laboratory Systems: Ensuring GxP Compliance in QC and R&D
Why CSV Is Critical for Laboratory Systems In today’s life sciences environment, laboratories play a central role in quality control
The Role of Quality Management Systems (QMS) in FDA Inspection Readiness
Understanding Quality Management Systems in Life Sciences A Quality Management System (QMS) is the backbone of regulatory compliance for pharmaceutical,
Mock FDA Inspections: A Critical Step for Life Sciences Companies
What Are Mock FDA Inspections? Mock FDA inspections are simulated regulatory audits designed to prepare pharmaceutical, biotechnology, and medical device
How to Train Your Team for FDA Inspection Success
Why Team Training is Critical for FDA Inspection Readiness Preparing for an FDA inspection is not just about systems and
FDA Inspection Readiness for Clinical Trials and CROs
Understanding FDA Inspection Readiness in Clinical Research In the highly regulated life sciences sector, FDA inspection readiness is essential for
FDA 483 Observations: Prevention and Effective Response Strategies
Understanding FDA 483 Observations When the U.S. Food and Drug Administration (FDA) inspects pharmaceutical, biotechnology, or medical device facilities, the
Data Integrity in FDA Inspections: Best Practices for Compliance
Understanding Data Integrity in Life Sciences Data integrity is a critical component of FDA compliance in the pharmaceutical, biotechnology, and
Internal and Supplier Audits: Driving Compliance and Supply Chain Integrity in Life Sciences
One Stop Solution for Life Sciences What Are Internal and Supplier Audits? In the life sciences industry—pharmaceuticals, biotechnology, and medical
The Role of Internal Audits in Driving Operational Excellence
Introduction: Internal Audits Beyond Compliance In the life sciences sector covering pharmaceuticals, biotechnology, and medical devices, internal audits are often
How Internal and Supplier Audits Improve FDA and EMA Inspection Readiness
Introduction: Audits as a Cornerstone of Compliance For pharmaceutical, biotechnology, and medical device companies, inspection readiness is not optional—it’s essential.
Comprehensive Internal and Supplier Audit Services by BioBoston Consulting
Introduction: Ensuring Compliance and Quality Across Life Sciences In the pharmaceutical, biotechnology, and medical device industries, regulatory compliance is critical.
Winning FDA Inspections: Best Practices for Life Sciences Companies
Introduction: Turning Inspections Into Opportunities For pharmaceutical, biotechnology, and medical device organizations, FDA inspections are critical milestones that determine compliance,
Mastering FDA Inspection Readiness: A Complete Guide for Life Sciences
Introduction: Why FDA Inspection Readiness Matters For pharmaceutical, biotechnology, and medical device companies, FDA inspections are not just regulatory requirements—they
FDA Readiness Made Simple: Preparing Your Organization for Regulatory Success
Introduction: Turning FDA Compliance Into an Advantage In the life sciences industry, FDA readiness is more than a regulatory requirement,
FDA Inspection Readiness: Key Steps Every Pharma and Biotech Company Must Take
Introduction: Why Inspection Readiness Is Essential In today’s highly regulated environment, pharmaceutical and biotech companies cannot afford to take FDA
FDA Audits Demystified: How BioBoston Consulting Prepares You for Success
Introduction: Taking the Fear Out of FDA Audits For pharmaceutical, biotechnology, and medical device companies, FDA audits are often viewed
Be Inspection Ready: How to Pass FDA Audits Without Stress
Introduction: Shifting From Fear to Confidence For many pharmaceutical, biotechnology, and medical device companies, the phrase FDA audit brings stress
FDA Inspection Readiness: Secure Approval, Confident Operations
One Stop Solution for Life Sciences In the stringent regulatory landscape of life sciences—whether pharmaceuticals, biologics, or medical devices—being prepared
Quality Assurance & Regulatory Compliance
In today’s competitive life sciences industry, success is defined not only by innovation but also by quality and compliance. For
Internal and Supplier Audits/ Life Sciences Compliance Experts
In the life sciences industry, compliance, quality, and patient safety are non-negotiable. One of the most effective tools organizations can
FDA Inspection Readiness: One Stop Solution for Life Sciences
In the life sciences industry, few events are as critical as an FDA inspection. Whether your company is developing pharmaceuticals,
QA Documentation and Record-Keeping: Keys to Regulatory Success
In the life sciences industry, maintaining accurate and comprehensive quality assurance (QA) documentation and records is essential for regulatory compliance,
How BioBoston Consulting Helps Organizations Achieve QA Excellence
In the highly regulated life sciences industry, maintaining Quality Assurance (QA) excellence is essential for ensuring product quality, patient safety,
How to Prepare for FDA Inspections Through Robust QA Processes
For pharmaceutical, biotechnology, and medical device companies, FDA inspections are a critical component of regulatory compliance. Being prepared for these
Partnering with BioBoston Consulting for End-to-End QMS Excellence
In the highly regulated life sciences industry, a robust Quality Management System (QMS) is critical for achieving compliance, operational efficiency,
Why Internal Audits Are Critical for FDA and Regulatory Compliance
In the highly regulated life sciences industry, achieving and maintaining compliance with FDA regulations and global standards is non-negotiable. Whether
The Role of Supplier Audits in Reducing Risk and Ensuring Product Quality
In the life sciences industry, suppliers play a critical role in ensuring the safety, quality, and compliance of products. From
Leveraging Internal and Supplier Audits to Prepare for FDA Inspections
In the life sciences industry, regulatory inspections are inevitable. The FDA expects organizations to maintain high standards of compliance across
Internal and Supplier Audits for GxP Compliance: A Complete Guide
In the highly regulated life sciences sector, GxP compliance covering GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and GLP
How Often Should Internal Audits Be Conducted Before FDA Inspections?
In the highly regulated life sciences industry, compliance is not a one-time effort—it requires consistent oversight and continuous improvement. One
Why Partnering with BioBoston Consulting Enhances FDA Inspection Readiness
In the life sciences industry, achieving and maintaining FDA inspection readiness is critical for success. Whether your organization is involved
What Is the Difference Between a Mock FDA Audit and a Real Inspection?
In the highly regulated life sciences industry, companies must consistently meet FDA standards across Good Manufacturing Practices (GMP), Good Clinical
The Role of Mock FDA Inspections in Achieving Compliance Excellence
In the competitive and highly regulated life sciences industry, regulatory compliance is non-negotiable. Companies operating under Good Manufacturing Practices (GMP),
How Do Mock Audits Help Prevent FDA Form 483 Observations?
In the highly regulated life sciences industry, receiving an FDA Form 483 can be costly and damaging for any organization.
How Do GMP, GCP, and GLP Mock Audits Differ?
In the life sciences sector, FDA inspections are a critical part of ensuring regulatory compliance and safeguarding patient safety. Organizations
FDA Inspection Readiness in GMP, GCP, and GLP Environments
In the highly regulated life sciences industry, FDA inspections are a critical checkpoint for ensuring compliance, product quality, and patient
Common FDA Inspection Findings and Strategies to Prevent Them
In the highly regulated life sciences industry, FDA inspections are a critical part of ensuring compliance, product quality, and patient
FDA Inspection Readiness: Safeguarding Compliance and Operational Excellence
One Stop Solution for Life Sciences In the highly regulated life sciences industry, preparing for an FDA inspection is crucial.