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On May 6, FDA announced that it would be stepping up its emphasis on foreign drug manufacturing facility inspections. Many overseas drug manufacturing facilities have not been inspected since before the COVID-19 pandemic (> 5 years). In addition, FDA’s facility inspections will no longer be announced to the overseas drug manufacturers ahead of time. Previously, non-US manufacturers received advanced notice of FDA inspections which gave them some time to prepare. US manufacturers, on the other hand, must be prepared at all times as all FDA inspections other than pre-approval inspections (PAI) are unannounced.
“For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track,” said FDA Commissioner Martin A. Makary, M.D, M.P.H.
Non-US manufacturers will now need to be prepared at all times for FDA inspections; this means that they should integrate inspection readiness into their routine operations, ensuring that established processes and procedures effectively support eventual unannounced regulatory inspections. Moreover, conducting frequent and unscheduled mock audits serves as a critical mechanism for evaluating and reinforcing inspection readiness.
The Biologics Consulting team can help companies prepare for FDA inspections. For the last 30 years, we have performed facility and quality system gap assessments, mock audits, develop recommendations for remediation of gaps, and assist companies with remediation activities. We have a group of ex-FDA inspectors, experienced auditors, quality management system (QMS) experts and technical subject matter experts who can perform these tasks.
If your company’s manufacturing facility or CDMO facility is located ex-US and has not been recently inspected by FDA, we advise you to prepare promptly for an inspection. We at BC are happy to provide you with advice and assistance in your preparations.
