FDA Issues Warning Letter to Chinese Company for cGMP Violations

On Jan. 6, 2017 FDA issued a warning letter to Cixi Zhixin Bird Clean-Care Product Co., Ltd for violations of current good manufacturing practice (cGMP) for finished pharmaceuticals. In the letter FDA noted, “because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).”

During an investigation of the facility, FDA officials said the company’s “quality control unit failed to review and approve all drug product production and control records, including those for packaging and labeling.” In addition, FDA said the company did not perform assay tests for each batch of final product to verify its content.

FDA also said the company did not keep any samples to determine product stability. The company had “no data to support the (b)(4) shelf life claim of your products.” Cixi Zhixin did not follow written procedures required to maintain batch uniformity and integrity, the agency wrote in the warning letter. FDA said, “Your firm failed to establish and follow adequate written procedures designed to assure batch uniformity and integrity of drug products that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch.” FDA recommended the company work with a consultant to assist the company in meeting cGMP requirements.