FDA Has Issued No Warning Letters for GMP Non-Compliance Since March
(Thursday, September 10, 2020]
Since FDA effectively stopped auditing manufacturers six months ago due the pandemic, no company has been found to be non-compliant. Whether this means lax enforcement or more compliant manufacturing is open to debate. It should be noted that up until 10th March, FDA had conducted 231 inspections, and issued 7 Warning Letters in about 2 months since the beginning of the year. In the 6-month period form 10 March to 10 September 2020, FDA conducted 37 GMP inspections and has not issued a single Warning Letter to any manufacturer. In comparison, during the same period last year FDA issued almost 30 Warning Letters and conducted close to 728 inspections. These are based on publicly available data on FDA’s inspections database. This does not include findings from any non-traditional compliance reviews since FDA suspended GMP audits in early March, as those reviews have not been published by FDA. It would be hard for FDA to take much action for negative findings from paper audits without confirming the same in an on-site inspection. The reduction in non-compliance observations, and the resulting fewer punitive actions would be expected due to reduced enforcement activities, but it is hard to correlate these with the reduction in the quality of drug products available to the consumers. It is not clear how long the reduced enforcement activities will continue. FDA inspections are a critical function of the agency and have been strongly correlated with maintenance of the quality supply in the US. One can be confident that FDA is equally concerned about non-compliance going unchecked and is looking for ways to stem the lag.