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FDA Lists Major Compliance Findings from Its Drug Audits in 2023
(Thursday, January 18, 2024) This week the FDA released its annual report on compliance inspections listing key observations made by its inspectors, giving current trends in non-compliance activities and related FDA enforcement activities. The report provides an overall picture of what FDA inspectors look for at the facilities they are auditing to help others prepare for the FDA inspections. While individual Warning Letters issued to companies published on the FDA website list the specific non-compliance at those facilities, the FDA annual report is useful for understanding the overall trends in non-compliance activities across diverse facilities and acts as a useful training and educational tool for compliance departments in the industry. Across the three major areas of compliance (GMP, GCP, and GLP), GMP non-compliance dominated the FDA’s concerns last year. Almost 9 out of 10 (89%) of the Warning Letters and violations observed by the FDA inspectors were related to GMP non-compliance. The GMP non-compliance observations can be further grouped into seven categories. About half of the GMP Warning Letters were related to the facilities being non-compliant with overall GMP requirements such as having deficient quality control units, deficient testing of components, containers, and closures, SOP and batch record deviations, other documentation issues, and cleaning and maintenance issues. Other manufacturing non-compliance issues were the manufacture of unapproved drugs or misbranding issues, refusal to provide access to and copying of records, improper compounding of drugs, improper registration or listing, inadequate vendor or supplier qualification, and adulteration. Compared to last year, according to the FDA, there was an increase in facilities not responding to the FDA’s request for records and additional information. The report does not comment on the reason for this increase in failure by a facility to not respond to documentation and information requests, but it could be that the responses submitted were not adequate or incomplete, and not that the facilities did not respond at all. In about one in five (22%) cases, the Warning Letter was issued after the first FDA audit indicating non-compliance observations that were so egregious that the FDA wanted an immediate correction. Usually Warning Letters give 15 days to correct non-compliance compared to FDA 483 letters that give a longer grace period for corrections. Interestingly, a third (28%) of the Warning Letters were based on remote inspections, a trend that is expected to rise in the coming years. Other than GMP findings, about 6% of FDA’s non-compliance observations were related to Good Clinical Practices (GCP) or Independent Review Board (IRB) violations. About 5% of the violations were related to internet pharmacies which seems low since online pharmacies are widely known to use non-compliance practices. The lower number of Warning Letters to online pharmacies could indicate FDA’s inability to audit such pharmacies and, hence, in FDA’s inability to issue specific findings. The report shows that GMP facilities should be more concerned about being prepared for FDA audits. Quality control and quality assurance (QC-QA) practices should be reviewed internally carefully for compliance. Also, companies should allocate sufficient resources to SOPs and documentation management. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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