Chinese Drug Firm to Stay on Import Alert After Noncompliance with Inspection
Chinese pharmaceutical manufacturer Fercy Personal Care Products will remain on import alert for violations of Current Good Manufacturing Practice (CGMP) regulations, lapsed registration, and failure to cooperate with an inspection, said the Food and Drug Administration in a warning letter dated Sept. 7. As such, Fercy’s drugs will remain subject to refusal of admission into the U.S.
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According to the letter, an FDA inspection at Fercy’s facility in Zhejiang, China, found numerous lapses in quality control procedures, among other violations of the CGMP regulations. Additionally, the firm didn’t register with the FDA in 2012, despite offering products for import into the U.S., FDA said.
During the inspection of Fercy’s facility on March 6, the company refused to provide documentation on drug products distributed to the U.S. and contact information for suppliers, FDA said. Then, the company ended the FDA inspection before the investigator determined that the inspection was concluded and before the agreed-upon end date of March 9. The early termination prevented the investigator from reviewing records related to the production, testing and holding of drug products intended for the U.S. market, it said.
FDA said that until Fercy grants access to its records, it will continue to place the company on import alert.