. Missing Tests for Identity lead to FDA Warning Letter | IGMPI

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Missing Tests for Identity lead to FDA Warning Letter

A Canadian manufacturer, Cellex-C International, Inc received a FDA Warning Letter issued on August, 2017 basis an FDA inspection.The inspection team lamented that not all batches of the manufactured drug product and the active substances used therein had been tested for compliance with the specifications before their release. According to the response given by Cellex-C, the tests had been performed by a contract laboratory.

The FDA criticised in their warning letter that the response didn't give enough insight on how the selection, qualification and monitoring of said contract laboratory was conducted.

The FDA asked Cellex-C to perform a specific test for identity of all incoming materials and should not rely on the supplier's analysis certificate alone.

Moreover, the company also did not state how they would implement the missingtests on incoming materials for further issues besides the test for identity in the future.