Missing Tests for Identity lead to FDA Warning Letter

Recommendation

10-12 October 2023
Barcelona, Spain

Validation of Analytical Test Procedures & Measurement Uncertainty
Qualification and Validation in an uncertain analytical world – a holistic approach

This FDA Warning Letter issued to Canadian manufacturer Cellex-C International, Inc. on 02 August, 2017 is based on an FDA inspection performed in January 2017.

The Warning Letter refers to the company's response from 07 August, 2017.

It was criticised 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 deems the response insufficient for two reasons:

For one thing, Cellex-C must at least perform a specific test for identity of all incoming materials. They may not rely on the supplier's analysis certificate alone.

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

Please also see the complete Cellex-C International, Inc. Warning Letter for more detailed information.