FDA official: Growing number of enforcement actions stem from inspection alternatives

Regulatory NewsRegulatory News | 01 November 2021 |  By 

Many of the US Food and Drug Administration’s (FDA) drug good manufacturing practice (GMP) warning letters and import alerts issued in fiscal year 2021 were based on product sampling and reviewing firms’ written responses to record requests, not from traditional onsite inspections.
So asserted Francis Godwin, director of Office of Manufacturing Quality (OMQ) in FDA’s Center for Drug Evaluation and Research (CDER) at a compliance and enforcement update at a 26 October Pharmaceutical Quality Symposium sponsored by the CDER’s Small Business and Industry Assistance (SBIA).
Godwin noted that that “historically, OMQ actions primarily used evidence from FDA inspections.” Yet the pandemic reduced FDA’s ability to conduct onsite inspections except for those deemed “mission critical.” As a result, the agency had to rely more on alternative tools, such as testing samples, using mutual recognition agreements (MRAs) with other regulators, or relying on information submitted in response to requests for records.
In FY 2021, FDA issued 80 warning letters and 43 import alerts related to drugs. Of the total number of warning letters issued, a majority, or 58.8% were based on testing samples, 26.8% were based on onsite inspections, 12.5% followed up on FDA’s reviewing records, and 2.5% resulted from a company’s refusal to provide records in response to a request.
This contrasts with FY 2020 where of the 81 warning letters issued, 97.5% resulted from onsite inspections and 2.5% came from testing samples. In FY 2019, all 99 warning letters were prompted by FDA inspections.
Godwin said that a similar shift is occurring in import alerts. Of the import alerts issued in FY 2021, 44.2% were based on sample testing, 27.9% were from FDA’s review of written records, and 20.9% resulted from a refusal to provide written records to FDA, while only 4.7% resulted from an onsite inspection. The remaining 2% followed from a refusal to allow FDA to inspect a facility.
In FY 2019, however, most of the import alerts, 54.4% were based on site inspections, while 42.2% resulted from a refusal to allow an inspection, and only 1.8% were based on testing product samples, while 1.8% were prompted by a firm’s refusal to provide information to a request for records.
FDA Symposium


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