FDA Warns Another Indian API Maker Over Data Integrity Issues

The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations.

During the March 18-21, 2014, inspection, FDA investigators observed that Unimark Remedies had no unique usernames, passwords or user access levels to prevent raw data from being deleted or altered. All employees had full privileges to the computer systems, with the ability to alter a wide array of data, and there were no audit trail functions to record data changes.

The investigators also noted that analytical testing data were poorly maintained and reviewed. For instance, there were raw data on undocumented stability samples, but no indication of where they came from and why they were tested, the warning letter says.

The FDA also dinged the Mumbai-based company for not including start or stop times in batch records and for having incomplete water testing records. In its response to a Form 483, the firm blamed its manufacturing staff for the poor documentation practices, and said the chemist and microbiologist each had neglected their work, the Sept. 28 letter says.

Investigators also saw evidence of pests in the facility, including a lizard, a bird’s nest and bird feces in the general raw material warehouse.

The FDA asked Unimark — which counts Teva, Mylan and Actavis as clients — to provide an evaluation of the extent of inaccuracies in its reported data, a risk assessment of potential effects of these deviations on data submitted in drug applications and a management strategy, including details of its corrective and preventive action plan. The agency also recommended hiring an outside cGMP consultant.

The warning letter is the first issued to an API maker in the new federal fiscal year, which began Oct. 1. In FY 2015, the FDA issued eight warning letters to API makers — all to foreign firms and all citing data integrity issues (Generic Line, Oct. 14).

Unimark did not return a request for comment by press time. Access the warning letter here: www.fdanews.com/10-14-15-UnimarkWarning.pdf. — Kellen Owings




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