FDA issues warning letter to French drug testing lab

fda
The FDA has issued a warning letter to a lab in Méru, France, which it says was not meeting FDA standards. (FDA)

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.”

RELATED: FDA warning letter smacks Indian lab for repeated shortcomings

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.

Suggested Articles

Merck KGaA has big plans for a site in Switzerland where it intends to knit together biologics development and manufacturing. 

Biocon’s key biosimilars plant in Bengaluru, India, has gotten mixed reviews from the FDA and has now received a Form 483 with five observations.

Krystal Biotech has started on a new manufacturing facility for eventual commercial supply of gene therapies in its pipeline.