Discover the top five observations from FDA inspections in the life sciences sector, including documentation issues, quality control problems, and more.
Inspections from FDA are essential to maintain the safety and effectiveness of products in life science. These reviews are intended to detect any failure or violation in manufacturing, testing and distribution of the medicine. This article will talk about the topmost five observations in FDA inspections for Life sciences companies.
Documentation and record keeping issues
Documentation and record keeping issues are one of the top five findings in FDA inspections. These problems could be anything from incomplete or false files, inability to keep records or data in general, not following right procedures for documentation and much more.
Quality Control Problems
In the case of FDA inspections, a frequent discovery is quality control problems. This may encompass things like insufficient testing, deviations from approved quality control measures or incomplete or insufficient product defect/residue investigations.
Facility and Equipment Issues
Commonly this is facility and equipment related issues, such as insufficient cleaning and sanitation, facility maintenance not up to par, or equipment that has not been calibrated or qualified.
Human Resources Development
FDA inspections also frequently identify personnel training and qualification related deficiencies. Such failures include lack of proper training or documentation of training, lack of qualification which typically goes back to improper procedures.
Problems Reporting Adverse Events
Problem areas with respect to adverse event reporting are also frequently seen in FDA inspections. These may involve under/oversufficient or omitted reporting, inadequate adherence to the established reporting process, and substandard investigation and evaluations of adverse events.
Challenges: Labeling advertising and other issues
This includes issues with labeling and advertising that are identified through FDA inspections, such as false or misleading labels, failure to comply with stated labeling requirements.
Conclusion
In the end, FDA inspections can pick up anything from manufacturing deficiencies and statutory violations to testing errors and distribution problems with life sciences products. The most common deficiencies that are found include inadequate documentation, record keeping, quality control issues, problems with facility and equipment reports, personnel training and qualification difficulties, improper response to adverse events reporting inaccurate labeling or advertising. With so much at stake, it is essential that life science companies address these same findings to show their commitment to quality and compliance, while also upholding a good relationship with the FDA.
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