FDA Warns Unimark API Facility in India

FDA issued a warning letter on Sept. 28, 2015 to API manufacturer Unimark Remedies Ltd. for cGMP violations at its facility in the Ahmedabad District of India, including evidence of pests in the facility and problems with documentation and data integrity. FDA investigators found, “what appeared to be a bird’s nest near the ceiling.  On March 18, 2014, the investigator saw bird feces on a rack and on a bag of (b)(4) in the general raw material warehouse #2.  On the same day, the investigator saw a lizard in the general raw material warehouse #1.” In the warning letter, FDA asked the company to “provide details of your pest prevention and control program and provide the results of your review of the effects of the presence of pests in your facility on API quality.”

FDA also recommended that the company hire a third party for help with its data-integrity problems. Investigators noted failure to document production and analytical testing activities at the time they are performed, failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data, and failure to maintain complete data derived from all testing and to ensure compliance with established specifications and standards.