FDA renews ban on Indian drugmaker after fresh violations
- The Food and Drug Administration harshly criticized Indian drugmaker Pan Drugs for widespread and significant violations of manufacturing standards, which were uncovered in an inspection last December and detailed in a recently released warning letter.
- Inspectors from the U.S. regulator found evidence Pan used adulterated active pharmaceutical ingredient (API) to manufacture drug products shipped to the U.S. last fall, noting the company's quality control unit at its Vadodara plant falsified certificates of analysis allowing the products to be released.
- The FDA has stepped up its oversight of Indian pharmaceutical companies, sending warning letters to nearly 20 different manufacturers over the last year and a half. Quality control concerns have persisted even as the role of India's pharma industry has grown in the global drug supply chain.
While many Indian drugmakers have been cited by the FDA for manufacturing violations over the past year, Pan's missteps stand out.
Even though Pan was placed on an import ban last May for "egregious cGMP deviations," the drugmaker continued to use adulterated API to manufacture its drug products. The warning letter cited data integrity violations in 11 batch production records and revealed Pan's production manager admitted to FDA inspectors he had falsified signatures certifying the products had been reviewed and approved.
Pan struggled to maintain basic sanitary standards at its Vadodara facility. Inspectors noted mold-like substances on the walls of the plant's drug processing area, along with signs of lizards and rodents inside the facility. Drug manufacturing equipment was observed to be dirty, rusty and leaky.
Despite the glaring sanitary concerns, Pan apparently had no cleaning procedures in place for either the equipment or the facility, according to the letter.
During the inspection, the FDA's inspector noticed Pan's warehouse supervisor tearing pages out of the firm's annual report and stuffing them into his pocket. After being confronted, the supervisor handed over the documents to the investigator.
This isn't the first time Pan has run afoul of the FDA, either. A July 2014 inspection of the another facility in Vadodara, India uncovered similar problems with the cleanliness of that plant and its equipment. At the time, Pan said it would repair and renovate the facility within two or three months, although the FDA noted its skepticism given the site had been under renovation three years prior in 2011.
In response to the latest violations, the FDA demanded Pan launch a comprehensive investigation into data inaccuracies, along with a risk assessment and review of its management strategy. Until the FDA confirms Pan has brought its facility into compliance, products from the site will be banned from entry into the U.S.
- FDA Warning Letter
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