FDA investigators found a record-keeping mess at an Indian drug manufacturer that they say raises concerns about the quality of the active pharmaceutical ingredients (APIs) that it shipped for use in U.S. drugs. Forged signatures of directors who were not in the plant were found on some records, and some signatures were backdated to indicate they approved drugs before they were shipped, when in fact, they hadn't.
In a warning letter posted this week for Mahendra Chemicals, the FDA was very explicit. In a 5-point directive, the FDA told the drugmaker it needs to investigate how widespread the "inaccuracies" were, figure out the possible impact they had on products, report what it intends to do about those products already released and the variety of ways it will clean up its act so the problems don't continue.
"We strongly recommend hiring a qualified third-party auditor/consultant with experience in detecting data integrity problems to help you comply with CGMP requirements," the warning letter says.
The problems were discovered during an inspection in May 2014 of the company's plant in Gujarat. Inspectors found that operators often logged batch records on "rough notes" that were later destroyed after being "transcribed" by someone else, leaving open the question of what the original data was and if it was altered in the final form. They also learned that the technical director not only signed off on results that someone else had collected, but he also backdated his own signature to when the batches were released.
Data integrity has been a big issue in the FDA inspections of Indian drugmakers, tripping up drugmakers large and small. Warning letters have been issued to plants owned by Ranbaxy Laboratories, Wockhardt and Sun Pharmaceutical, in part, over concerns that data is being manipulated, leaving questions about whether their drugs meet standards. The same problem has been found in plants in China and elsewhere.
- here's the warning letter