An FDA inspector didn’t have to spend long to discover that a Canadian API maker was failing to meet FDA standards for product testing, not to mention finding insects and spiders in its packaging area.
The FDA posted a warning letter this week that was sent to Les Produits Chimiques in Pointe-Claire, Québec. The two-observation warning followed a one-day inspection last fall during which it was found that the company was not testing for identity of API powder that had sold into the U.S. even though the certificates of authenticity clients received insisted they had been.
“Your firm confirmed to our investigator that, although your COA states that the identity tests 'Passed,' you did not perform the tests,” the FDA wrote. “Although you never performed the required testing, you distributed these API lots to the U.S. market with false information on the COA.”
The plant was also criticized after the inspector found that samples intended for stability studies were not stored in an area with controlled temperature and humidity. It also said “At least twice, our inspector observed insects and spider webs in and on plastic-wrapped stacked containers used for packaging API.”
The letter suggested the facility hire a consultant that could help it meet all required cGMP requirements.