WL Zhuhai Aofute Medical Technology Co., Ltd. MARCS-CMS 590945 — JANUARY 09, 2020
- 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)).
You failed to establish an independent and effective quality unit. For example, you failed to adequately perform basic quality unit (QU) responsibilities, including but not limited to:
- Approval or rejection of all components and drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.
- Review of all production and control records.
- Assure establishment of adequate batch records.
- Approval of procedures and specifications impacting on the identity, strength, purity and quality of all drug products.
Notably, you lacked adequate production and laboratory records. Your firm did not demonstrate the appropriate controls to assure drug product batches were manufactured following appropriate written procedures. Because no meaningful production records were available, there is no assurance that, if errors occurred, they were fully investigated before batches were released. Furthermore, your laboratory technician stated that original raw data is routinely discarded...
