Learn about the most common findings during FDA inspections in the life sciences industry, including documentation issues, quality control problems, and more. Discover how to address these issues and ensure compliance with FDA regulations. Contact BioBoston Consulting for expert guidance.
FDA inspections are routine events as part of the safety and efficacy enforcement process in life science.
These inspections are designed to uncover and remediate any problems or violations that may exist in the manufacturing, testing, and distribution of a product.
Top 5 Common Findings in FDA Inspections
Documentation & Recordkeeping
Documentation & Recordkeeping Issues are a frequent finding for many FDA inspections. These troubles encompass incomplete or flawed data, the incapability to maintain information or records, and failure to follow standard operating procedures for documentation and storing data.
Quality Control Problems
Likewise, quality control issues are a common discovery in FDA inspections. This may involve poor validation practices, lack of adherence to standard quality control procedures or inadequate resolution and investigation around product defects and complaints.
Facility and Equipment Issues
Facility and equipment-related issues such as failure to clean and sanitize properly, Failure to maintain instrumentation adequately, Lack of proper calibration or qualification of equipment.
Training and Qualification of Personnel
Training and qualification issues are common observations during FDA inspections This includes Inadequate training / failure to document of training, Lack of proper qualifications for staff and Failure to follow established procedures
Issues with the Adverse Event Reporting
Reported adverse event issues are another top FDA inspection finding. There are more reasons due to insufficient or incomplete reporting, not following existing procedures for reporting/gagging etc. and not investigating / evaluating adverse events.
More About Labeling and Advertising
FDA inspections might also uncover problems related to labeling and advertising, such as poor labeling or false labeling, lack of adherence to defined packaging requirements or improper or fraudulent advertising.
Conclusion: Ensuring Long-Term Compliance and Success
FDA inspections of Investigation and Response plans can reveal a wide variety of deficiencies and violations related to the manufacture, testing, distribution of life science products.
The most common compliance issues relate to problems with documentation and recordkeeping, quality control, facility or equipment issues, training and qualification of personnel, reporting adverse events processes for marketed products for which the novel applications are pending/accepted/have been converted (to class II status), labeling or advertising.
In addressing these findings, companies in the life sciences industry can indicate their quality and compliance allegiance and retention of favor with the FDA.
If you would like to know more about how we can help your organization, please get in touch with BioBoston Consulting or visit our website.
