Explore the most common findings from FDA inspections in life science companies, including issues with documentation, quality control, training, and adverse events.
FDA Inspections are an integral part of the life science industry concerned with assuring products safety and efficacy. They are performed to highlight potential deficiencies or violations in the manufacturing, testing and distribution of products. This article provides an insight into the most common observations made by FDA inspectors in life science companies.
Issues with recordkeeping and documentation
Documentation and recordkeeping issues are one of the most common findings seen in FDA inspections. Such issues can be among incomplete or incorrect records, not maintaining documents or data, not following established procedures for documentation.
Quality Control Problems
The instances of quality control issues form another area where FDA inspections often result in a finding. This may be due to insufficient testing, not adhering to established quality control procedures, and investigating defects or complaints about products left undone or done poorly.
Facility and Equipment Issues
The most common facility and equipment observations from FDA inspections include poor cleaning and sanitation, poor maintenance, improper calibration or qualification of equipment.
Personnel Training and Qualifications issues
Examples of other often cited problems related to personnel training and qualification found during FDA inspections include insufficient training or documentation of training, no qualifications for staff, and not following procedures that are in place.
Challenges/Issues in Adverse Event Reporting
Another frequent finding during FDA inspections are issues with reporting adverse events. These include poor or incomplete reporting, not adhering to established processes for reporting, and not sufficiently investigating and assessing AEs.
Problems in Labeling and Advertising
The FDA inspections can also bring about labeling and advertising issues, such as improper or inaccurate labeling, failure to comply with regulations governing labeling, and false or misleading advertisements.
Conclusion
To summarize, FDA inspections can discover many different types of deficiencies and violations in the manufacturing, testing and distribution of life science products. These often encompass documentation and recordkeeping practices, quality control complications, facility and equipment concerns, personnel training and qualification problems, adverse event reporting ramifications and labeling and advertising predicaments. Addressing those findings can allow life science companies to show seriousness towards quality and compliance so that FDA never slips away from their side.
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