US FDA issues a warning letter to Canton Laboratories

The US FDA issued a warning letter to Canton Laboratories for cGMP violations for the manufacture of active pharmaceutical ingredients (APIs), including reporting results for tests it never performed to measure microorganisms in active ingredients and failing to ensure equipment was cleaned to prevent contamination. Canton Laboratories is a manufacturer of fine chemicals and bulk drugs such as pharmaceuticals, food, healthcare etc.

FDA inspected the pharmaceutical manufacturing facility of Canton Laboratories located at Vadodara in April 2013. During the inspection it was found that there were significant cGMP violations related to laboratory testing of API, record maintenance etc. The inspection revealed serious documentation practices and reported missing raw data.

FDA also observed that the company fails to follow Master Validation Plan for process validations or equipment calibrations, fails to perform appropriate stability studies for product currently in the market, fails to provide adequate resources to the quality unit etc. The companys quality unit was not able to properly review production records and detect instances where testing was not performed to support companys certifications on Certificate of analysis.