Missing Tests for Identity lead to FDA Warning Letter
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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.
Related GMP News
03.02.2026Your Input is Requested: AQCG Survey on OOS Investigations
03.02.2026Questions and Answers on System Suitability Tests (SST) - Part 2
03.02.2026Eurachem Publishes New Guide on the Fitness for Intended Use of Analytical Equipment and Systems
14.01.2026FDA Warning Letter: OOS Handling and HPLC Method Validation
07.01.2026Revised Ph. Eur. Chapters 2.9.42 and 2.9.43 on Dissolution Testing
07.01.2026Korean MFDS Publishes Data Collection on Dissolution Test Methods