Discover the most frequent findings during FDA inspections of life science companies, including documentation issues, quality control violations, and labeling compliance problems.
If you are in the life science space, then you know that FDA inspections are a key part of ensuring products are safe and effective. The purpose of these inspections is to detect any deficiencies and/or violations in the manufacturing, testing, and distribution of products. Here, we are going to review the most frequent findings from the FDA inspection for life science companies.
Problem with Documentation and Recordkeeping
Documentation and Recordkeeping Findings/FDA Inspection Issues– Among the most frequently cited findings in FDA inspections are problems relating to documentation and recordkeeping. These can be due to Missing or Inaccurate records, not maintaining documents or data and not following procedure for documentation.
Quality Control Problems
FDA inspections frequently discover quality control issues such as insufficient testing, not following the established standard of quality control and not fully or appropriately investigating product defect or complaint.
Facility and Equipment Issues
Facility and equipment failures are common observations from FDA inspections, including failure to clean and sanitize properly, poor maintenance practices, or lack of equipment calibration/qualification.
Training and Qualification Issues for Employees
Another frequent observation made during FDA committee inspections is poor personnel training and qualification practices. Such lapses may be in the form of insufficient or no training, no proper qualification, and/or no adherence to procedures.
Problems With Reporting Adverse Events
The other issue that the FDA often finds during an inspection is deficiencies in adverse event reporting. These include issues such as not reporting at all, submitting incorrect information; procedural issues such as failure to maintain compliance with established methods of reporting; investigation and evaluation issues such as improper documentation in assessing AEs.
Problems with labeling and advertising
FDA inspections can also uncover problems with labeling and advertising use—such as minor or major misbranding, failure to comply with established label requirements, and unlawful promotion or misleading advertising.
Conclusion
In summary, FDA inspections can find numerous manufacturing, testing and distribution deficiencies and violations relating to life science products. Among the frequently observed findings are documentation and recordkeeping deficiencies, Quality Control deficiencies, facility and equipment problems, personnel training and qualifications violations, adverse event reporting issues and promotional labeling and advertising concerns. Life science companies need to acknowledge these findings and ensure that they are committed to quality, compliance standards, and maintain a positive relationship with the FDA.
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