Institute of Good Manufacturing Practices India®

USFDA warning letter to Hangzhou Badi Daily Use Chemical Company

The U.S. Food and Drug Administration (FDA) conducted an inspection of Hangzhou Badi Daily Use chemical company, drug manufacturing facility located at Huzhou City, Zhejiang Province from March 19 to 21, 2019.

The warning letter summarized significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Warning letter includes points such as methods, facilities, or controls for manufacturing, processing, packing, or holding which are not in compliance to CGMP; depicting the modification of drug products from section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

Specific CGMP violations were observed by the inspector including:

  1.  Failure of the firm in having separate batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications.
  2.  Failure of the firm in conducting at least one test for verification of the identity of each component of a drug product.
  3.  Failure of the firm in establishing adequate documentation for production and process control designed.
  4.  Failure of the firm in assuring that the drug product has an expiration date that was supported by appropriate stability testing.