FDA warns drug maker about inadequate quality control
Topics: FDA DRUG QUALITY
The warning letter issued to Ningbo Huize details a failure to have adequate quality control mechanisms in place. The company provided FDA investigators multiple documents that were falsified, including the cleaning validation reports and batch production and control records for multiple drugs.
The firm also provided records showing they performed the required periodic reviews of their operation to assure quality, which they later admitted were also falsified. These CGMP violations cause all drugs manufactured by Ningbo Huize to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The company has agreed to voluntarily recall drugs. The FDA requested a response from the company within 15 working days of receipt of the letter. ■