FDA warning letter says China OTC maker halted inspection midstream

The FDA has issued an import alert against a Chinese over-the-counter product maker that kicked inspectors out of its plant  midstream. According to a warning letter, dated Sept. 7 and posted on the FDA's website this week, inspectors were in the Fercy Personal Care Products plant in Jinhua, Zhejiang, China, on March 5 and 6 but officials there stopped the inspection on the second day. This led the FDA to determine that the company was not meeting agency standards. While they were there, investigators found no indication that suppliers were meeting specs and found no written procedures to show that products met potency standards or that the company was testing batches to determine if they were. The company's website indicates that it makes OTC products sold to "dollar stores, supermarkets, mass merchants and drug stores." The FDA says Fercy will remain on import alert, meaning that its products will be refused entry into the U.S. and that the FDA will not accept any product applications until problems are fixed and the FDA is allowed back in to determine that they are. The incident comes as the FDA is upping its commitment to inspecting foreign manufacturers, particularly in China, which has been the source of issues in the past. FDA letter | More

Suggested Articles

McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.

The FDA made public a voluntary recall of sterile injectables made by Coastal Meds of Mississippi, after visible particles were found in some vials.

It’s been a strange road for BMS' Opdivo-Yervoy combo in first-line kidney cancer, but the New Jersey drugmaker finally has a go-ahead.