Inadequate Inspections and QA Oversight Dominate FDA 483s for GMP Sites
(Thursday, September 8, 2022)
Last year, the most common FDA 483 finding from inspections of drug manufacturing sites was non-compliant handling of deviation investigations and inadequate quality unit oversight. Inadequate CAPA, data integrity issues, and deficiencies in training of personnel wrapped up the top 5 major findings by FDA inspectors. The annual report on the GMP compliance in the industry published by FDA’s Office of Pharmaceutical Quality (OPQ), lists several interesting factoids about the status of the manufacturing industry such as the wide distribution of manufacturing sites across the globe, common products manufactured, increased use of remote inspections by FDA, and the impact of the Covid pandemic on overall quality of drugs. But the most relevant and usable matrix is the common audit findings that led to the FDA 483s. GMP sites are expected to conduct detailed inspections for all deviations and adverse incidences and create detailed reports of such investigations. FDA found issues with thoroughness of the investigation, lack of timely resolutions, or inadequate details in the investigation reports. Since, investigations are conducted in close collaboration with the Quality units (Quality Control and Quality Assurance), deficiencies in inspection obviously led to the conclusion of inadequate quality oversight. And these findings connect with more issues found with CAPA, data integrity and training. Although these may seem as independent issues, they are interconnected as one leads to the other. FDA’s purpose with these reports is to make the overall industry aware of the common areas of concern so that other companies can review and address such issues and be better prepared for compliance inspections. The report also provides insight into FDA’s inspection practices and trends which are invaluable information for GMP facilities.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC