The FDA placed a Divi’s Laboratories API manufacturing facility in India on an import alert.
FDA issued a Form 483 for the facility in December 2016, noting GMP compliance issues including a failure to exercise proper controls over computerized systems. It also found the facility had not ensured the purity, quality, strength and identity of its APIs.
The facility’s R&D division also fell short on GMP requirements, with the FDA inspection turning up several examples of products failing to meet specifications.
After receiving complaints in June 2016 of potential contaminants in its products, the facility failed to conduct a thorough investigation of the problem, according to the FDA. The agency also accused Divi’s of failure to maintain records and of falsifying some records. The inspectors found several intact documents in the incinerator dating back to April 2016.
Ten products from the facility are exempt from the alert: Gabapentin, Lamotrigine, Capecitabine, Levetiracetam, Naproxen sodium, Raltegravir potassium, Atovaquone, Chloropurine, BOC core succinaten and 2, 4-wing active ester.