Jubilant Generics FDA-483

FDA has released the form FDA-483 issued following a 7/20-8/1 inspection at Jubilant Generics, a Uttaranchal, India, drug manufacturer. The six inspection observations were:

• failing 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;
• written records are not always made of investigations into unexplained discrepancies;
• written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up;
• the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed;
• established laboratory control mechanisms are not followed and documented at the time of performance; and
• batch production and control records do not include complete information relating to the production and control of each batch.