Foreign Inventory Completion, Faster Inspection Follow-up Among CDER Compliance Office 2018 Achievements; API, OTC Process Findings Spotlighted

The Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) is reporting that during FY 2018 FDA nearly completed the inspections of its foreign manufacturing inventory – a full year earlier than agreed to with the General Accounting Office (GAO).

The agency had committed to GAO to inspect all of its previously uninspected foreign drug inventory – approximately one-third of the 3,000 facilities in it – over the three-year period FY17 to FY19. At the end of December 2017, the agency had already conducted 75% of these inspections and has completed almost all of the remainder during 2018.

One result has been a surge in the issuance of warning letters to foreign OTC manufacturers, who were a heavy component of the uninspected inventory.  Only a handful of OTC firms received the warnings in 2015, while the number surged to 39 in 2017. An additional thirteen letters went to OTC foreign firms during the first half of 2018.

Salient in these OTC warning letters have been ‘rudimentary’ GMP violations such as failure to conduct release testing or to establish a quality unit. These rudimentary issues have been apparent globally and not exclusive to a geographic region.

A review of FDA’s progress and findings in filling in the gaps in its drug manufacturing foreign inspection coverage was included in an update on CDER compliance office activities by its Director Don Ashley at the PDA/FDA annual meeting in September in Washington, D.C.

The review encompassed: ● OC’s five-year strategic plan ● the concerns FDA has been uncovering during its inspections regarding active pharmaceutical ingredient (API) impurities and supply chain obfuscation ● progress on implementing the 90-day inspection classification timeline, and ● enforcement action trends. [For the CO update by Ashley at last year’s PDA/FDA conference, see IPQ December 14, 2017.]

Ashley’s talk was complimented the next day at the conference by a presentation by OC Office of Manufacturing Quality (OMQ) Acting Director Francis Godwin in which he probed more deeply into the recent inspection findings and compliance trends.

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