FDA Warns Chinese Drug Company About Manufacturing Practice Violations

The Food and Drug Administration has told Fercy Personal Care Products Co. that it found significant violations of current good manufacturing practice (cGMP) regulations at the company’s pharmaceutical manufacturing facility in Zhejiang, China, according to a warning letter posted Sept. 18 on FDA’s website.

FDA said it found the violations during an inspection that ended March 6. The agency also said the company failed to register and list its drug products, as required.

Specific violations observed during the inspection include, but are not limited to:

• the company’s quality control unit did not exercise its authority to approve or reject drug ...