After a testing lab in France was caught using unvalidated methods on some drug testing for clients, it told the FDA it had a solution. It would simply inform customers on their certificates of analysis that further testing was needed. The FDA had another idea. It issued a warning letter.
The FDA posted the warning letter last week to Quali-Controle and Quali-Controle C.E. BAC which was tied to an inspection of its lab in Méru, France, in September 2017. In it, the FDA explained that just telling customers its testing was not all validated would not cut it.
“It is essential for a contract test laboratory to use validated or verified methods to ensure that results of pharmaceutical analyses subject to CGMP are accurate. … Including a disclaimer does not release you from the CGMP requirement to ensure that your test methods are validated and suitable for their intended use.”
In addition to validating its testing, the FDA told Quali-Controle President Emmanuel Souhaut that the facility needs to document for the agency how it intends to inform U.S. customers about all of the products they have already received that were tested using the unvalidated results.
The lab was also criticized for blaming two out-of-spec test results on dirty glassware, but the FDA said it had no justification for doing that.
The FDA has gone after labs before. In 2015, it issued a warning letter to Sipra Labs in Hyderabad for a variety of shortcomings.