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FDA sent warning letters detailing violations of current good manufacturing practices to three companies that repack APIs.
FDA issued warning letters to API repackers-B&B Pharmaceuticals, Inc.; Asclemed USA, Inc., doing business as Enovachem; and Spectrum Laboratory Products, Inc.-for violations of current good manufacturing practices (CGMPs). The violations range from certificates of analysis with incomplete information and failure to investigate complaints.
B&B Pharmaceuticals was warned by the agency for failing to thoroughly investigate complaints about sub-potent API and not conducting proper cleaning validation studies. The company failed to demonstrate that they were preventing potential cross-contamination between repackaged API. In addition, critical information about quality and sourcing of components was not included in certificates of analysis (CoAs). “Omitting this vital information from a certificate of analysis compromises supply chain accountability and traceability and may put consumers at risk,” the agency stated in a press release.
Enovachem failed to maintain traceability of API throughout the supply chain, according to FDA. The company had failed to obtain documents and CoAs from the original manufacturer. API was distributed to customers with incomplete CoAs, including to compounding pharmacies.
Spectrum also did not provide complete information in its CoAs. The company also did not properly investigate and resolve critical CGMP deviations, including cracked bottles of repackaged opioids, among other violations.
“Repackers play a role in the pharmaceutical supply chain, and some distribute bulk API to drug manufacturers and pharmacy compounders. The US drug supply chain remains one of the safest in the world, yet because of the various players and increased globalization, it has become increasingly complex. FDA remains vigilant in our inspections and oversight of the supply chain and as part of this effort, we inspect API repackers to help identify and prevent any weaknesses in the legitimate supply chain-this is especially important within the context of the opioid crisis for those who handle opioids,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in a press release. “The supply chain issues we have found in the API repacking industry broadly pose a real threat to the public health and we’re calling on them to address these issues as quickly as possible. For patient safety and supply chain transparency, repackers must follow all quality standards pertaining to them-including clearly identifying the original manufacturer of the drugs, such as opioids, to their customers who use them to make the finished drugs patients take every day. This information is vitally important to ensure the drugs patients take meet high quality standards that patients deserve.”