WARNING LETTER NingBo Huize Commodity Co., Ltd. MARCS-CMS 581345 — AUGUST 02, 2019
CGMP Violations
1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22 (a)).
During our inspection of your facility, your quality staff provided multiple quality documents to our investigator. Based on concerns with the documents provided, our investigator questioned your Quality Manager regarding the validity of these documents. Your General Manager and Quality Manager, then stated that multiple documents provided were in fact falsified “for the purpose of this inspection.”
Falsified documents include cleaning validation reports, batch records for multiple drug products, and annual product reviews. Furthermore, you also stated that you could not provide basic records to support the CGMP requirements for the manufacture of drugs, including, but not limited to, the following:
- equipment qualification (21 CFR 211.63);
- raw material qualification and active pharmaceutical ingredient testing (21 CFR 211.84);
- finished product and raw material testing qualification (21 CFR 211.165);
- drug product stability program (21 CFR 211.166);
- batch records (21 CFR 211.188); and
- process validation (21 CFR 211.100)...
In your response to this letter, provide:
- A full summary of data integrity assessments performed by your third-party consultant. Include a copy of your protocols, which should include a detailed description of all aspects of your operation that were subject to independent evaluation, and the depth and extent of the assessments. See the Data Integrity Remediation heading below for the full remediation request.
