When FDA inspectors make a site visits, there are a lot of things they don’t want to see, and spiders are probably near the top of the list. A recent FiercePharma article discussed a two-observation warning letter administered to Les Produits Chimiques in Pointe-Claire, Québec. Apparently the company was not testing for identity of API powder being sold in the U.S. with false certificates of authenticity.
The plant also failed to store stability study samples in an area properly controlled for temperature and humidity. The icing on the cake was the inspector observed insects and spider webs in and on plastic-wrapped stacked containers used for packaging API on multiple occasions. The warning letter suggests the facility hire a consultant to help get them up to code.
