FDA issues a warning letter to Apotex Pharmachem for data issues

The US Food and Drug Administration has issued a warning letter to Canadian based Apotex Pharmachem for cGMP violations at its Bangalore plant. The significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs) was observed.

During the inspection, FDA found that the company failed to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards. The inspection revealed that batch samples were retested until acceptable results were obtained. In addition, the quality control (QC) laboratory failed to include complete data on QC testing sheets. The raw laboratory data records for API batches shipped by the company were also missing.

The company failed to investigate and document out-of-specification results. The company was not able to investigate the unknown peaks found during the HPLC testing for related compounds of API batches. In the finished product report review data, it was reported that unknown peaks were observed due to vial contamination. The management failed to prevent practices of product sample retesting without investigation, and rewriting and/or omission of original CGMP records persisted without implementation of controls to prevent data manipulation.

The firm also failed to include adequate documentation during complaint investigation and to record activities at the time they were performed. According to FDA, the workers retested active ingredients until they got desirable results and dismissed sign of contamination. And FDA asked for the list of Apotex ingredients in circulation and said it may withhold approval of new product applications if the medicines are planned to be made with raw materials from the plant.