The FDA issued a warning letter to an API manufacturing facility in Hyderabad, India, citing adulteration, misbranding and other issues.
The agency labeled the Sal Pharma facility’s APIs as adulterated because of inadequate manufacturing, processing and packing controls, following an inspection in late June 2016. The agency placed the firm on an import alert Feb. 15.
The FDA investigators observed failures to transfer quality or regulatory information to customers, as well as problems with relabeling and holding of APIs.
The company omitted the names and addresses of the original manufacturers of the API on certificates of analysis sent to customers, according to the warning letter dated April 20, and generated COAs by replacing the original manufacturers’ information with its own letterhead, the agency said.