Institute of Good Manufacturing Practices India®

Warning letter issued to Stason Pharmaceuticals for violating current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.


The USFDA inspected the drug manufacturing facility of Stason Pharmaceuticals, Inc., and observed significant violations of current Good Manufacturing Practice regulations for finished pharmaceuticals.

The methods, facilities, controls for manufacturing, processing, packing, or holding failed to comply with the CGMP specifications.

The firm failed to investigate the discrepancies in the dissolution attributes of the drug temozolomide in form of capsules. Multiple lots of the medication failed dissolution tests during the stability studies. The company could not investigate the root cause of the failure and neither implemented any adequate corrective preventive action (CAPA) for future evaluations. In addition, the firm lacked in taking up measures to address cleaning issues for cleaning verification and validation outcomes of methotrexate tablets.

The firm also failed to impose appropriate controls over computer or related systems to assure the integrity of electronic test data. During the inspection, it was revealed that the computer operating the spectrophotometer was not secured and integrated, whereas the instrument was used for finished product release and stability testing for several drug products.

The quality system of the firm could not ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs.

The USFDA recommended the firm in engaging qualified consultant for assistance in meeting with the CGMP requirements.