US FDA issues a warning letter to Sun Pharmaceuticals for cGMP violations

The US Food and Drug Administration issued a warning letter to Sun Pharmaceuticals for cGMP violations for finished pharmaceuticals manufacturing facility in Karkhadi, Gujarat. The US FDA observed two violations in API manufacturing and three violations in finished product manufacturing.

Sun Pharmaceuticals is a multinational pharmaceutical company engaged in manufacturing of pharmaceutical formulations and Active pharmaceutical ingredients. The company offers formulations in different therapeutic areas like cardiology, psychiatry, neurology, gastroenterology and diabetology.

FDA inspected the API manufacturing facility and identified serious cGMP violations. FDA observed that the company failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards. The fundamental raw data and information necessary to document the analysis was missing. The firm frequently performs unofficial testing of the samples, neglects the results and reports the results from additional tests. Similar improper data handling practices were observed in laboratory’s conduct of gas chromatography (GC) analysis. The FDA also observed that the firm failed to assign and identify raw materials with a distinctive code, batch, or receipt number, and to identify the disposition of materials.

FDA inspectors also observed significant violations regarding the finished drug product manufacturing. The company failed to apply appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records. The written production, control, or distribution records specifically associated with a batch of a drug product for at least one year after the expiration date of the batch were not maintained. The firm also failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions.