IGMPI India

U.S. Food and Drug Administration (FDA) has issued warning letter to Mahendra Chemicals manufacturing facility, Gujarat, India. During the inspection USFDA identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs).

•  Failure to record activities at the time they are performed and destruction of original records.
•  Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent omission of     data.
•  Failure to train employees on their particular operations and related CGMP practices.

These deviations causes APIs to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act, in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP. The examples in this letter are serious CGMP deviations. FDA recommended the firm hiring qualified third-party auditor/consultant with experience in detecting data integrity problems to help to comply with CGMP requirements. In response to this letter, FDA asked for the following information from Mahendra Chemicals:

1. A comprehensive evaluation of the extent of inaccuracies in reported data.
2. A risk assessment of potential effects on drug product quality.
3. A management strategy for the firm, including the details of corrective action and preventive action plans.

FDA has given 15 working days to respond to this letter from receipt of this letter.