Torrent Pharmaceuticals FDA-483

FDA has released the form FDA-483 issued following a 6/3-6/12 inspection at the Torrent Pharmaceuticals finished product and non-sterile active pharmaceutical ingredient manufacturing facility in Indrad, Gujarat, India. The inspection observations were:

• failure to have a testing program to assess the stability characteristics of drug products;
• failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed (repeat observation);
• failure to clean and maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product (repeat observation);
• failure to establish written procedures for the testing of materials as well as recording or storage of laboratory data; and
• failure to maintain an adequate clean washing facility for personnel.