FDA Cites India API Facility For CGMP Violations

FDA issued a warning letter to an API manufacturer, Pan Drugs Limited (Vadodara, India), on Sept. 2, 2015, citing improper maintenance, repair, and cleaning of buildings used to manufacturer APIs. FDA investigators observed holes in the walls and roof that gave pigeons access to areas where production equipment was used. They also observed gaps and holes in outside walls near piping and air ducts that could allow contaminates to enter the facility. The company also failed to maintain equipment used to manufacture APIs, according to FDA. Investigators “observed rust, dirt, lubrication leaks, and exposed insulation material on and around open drug manufacturing equipment.”

The company was also cited for failure to maintain complete analytical testing data. FDA says that for a specific lot, analytical testing documentation provided to the agency indicated that no heavy metals analysis was performed; the name of the analyst who performed the residual solvents analysis was not included; and no second person reviewed the documents for accuracy, completeness, and compliance with established standards.

FDA is recommending the company obtain a third-party consultant to assess the firm’s operation and that the company contact the Center for Drug Evaluation and Research’s Drug Shortages Staff for help bringing the company into compliance to minimize the affect on the drug supply.

Source: FDA