Following a July inspection, the FDA issued a warning letter to Pan Drugs Limited of Nandesari, India, on Sept. 2. According to its website, Pan Drugs manufactures acetaminophen/paracetamol (pain and fever reducer), guaifenesin (expectorant), and methocarbamol (muscle relaxer).
The FDA inspection “identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients.” Among the citations: Gaps and holes in outside walls for piping and air ducts allowing outside contaminants into the building; rust, dirt, lubrication leaks, and exposed insulation material on and around drug manufacturing equipment; and pigeons near production equipment in several areas of the facility, after flying into the building via holes in the roof.
The FDA says that Pan Drugs Limited continued to manufacture product intended for the U.S. market even after the company recognized that the facility and equipment were not in compliance with CGMP requirements. A June 2014 change control from Pan Drugs stated, “Warehouse and Facility to be upgraded to achieve GMP standards.” However, in July 2014, the company still manufactured API batches, but they ceased manufacturing operations on July 12 once they were notified that the FDA would be coming to inspect the facility.
The letter acknowledged that Pan Drugs committed to complete various repair and renovation activities within 60 to 90 days, with the intention to assure a suitable facility; but in the same paragraph, the FDA also pointed out that Pan Drugs made a similar promise back in May 2011 which obviously had little effect. The FDA also expressed doubt as to whether the information that Pan Drugs provided during the inspection was, in fact, accurate and truthful.
The FDA has requested that Pan Drugs provide photographic evidence that you have fulfilled your commitment to fully renovate the facility, and demonstrate that the entire facility meets CGMP requirements. The drug manufacturer must also provide a list of all lots distributed to the U.S., within expiry. It has been recommended that Pan Drugs hire a third party consultant with appropriate CGMP expertise to comprehensively assess the company’s entire operation, including facility conditions, procedures, processes, laboratory controls, and quality management systems.
Until Pan Drugs provides the FDA with proof that it has made the necessary corrections, the company will remain on Import Alert 66-40.