Torrent Pharmaceuticals FDA-483

FDA has released the form FDA-483 with five inspection observations that was issued to Torrent Pharmaceuticals following a 12/5-12/11/2023 at its drug manufacturing facility in Gujarat, India. The five 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 been distributed;
• failing to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit for formulation manufacturing operations;
• failing to clean and maintain equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
• components for drug product manufacturing are not weighed and measured; and
• failing to establish the accuracy, sensitivity, specificity, and reproducibility of test methods.