FDA Issues Warning to Repackers for Violating Manufacturing Quality Standards

July 5, 2019

The FDA has warned three repackers of active pharmaceutical ingredients (API) over violations of current good manufacturing practice requirements. Letters to B&B Pharmaceuticals, Enovachem, and Spectrum describe potential cross-contamination, cracked bottles, failure to provide complete certificates of analysis, and more.

“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,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “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.”

Read the press release.