Canadian Manufacturer Warned for Adulterated APIs

The FDA warned Montreal, Quebec-based drugmaker Les Produits Chimiques that serious quality unit failures caused its APIs to be adulterated.

During a September 2017 inspection, the agency found multiple deficiencies in the quality unit’s performance in ensuring that the APIs were compliant with current good manufacturing practices.

Specifically, the firm didn’t keep samples bound for stability studies in temperature and humidity controlled storage areas. Instead, it kept them in a laboratory cabinet without monitoring the temperature and relative humidity.