Zhejiang Casing Animal By-Products Co. Ltd – FDA Warning Letter, Nov 4, 2010

On August 5, 2011, the FDA issued a Warning Letter to Zhejiang Casing Animal By-Products Co. Ltd. following a November 1-4, 2010 inspection of their drug manufacturing facility in Tonglu, China. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) for drug manufacturing, rendering their (b)(4) product adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations include: 1. **Quality Unit Oversight:** Failure of the quality unit to review complete laboratory control records for critical process steps, specifically (b)(4) and HNMR testing, before drug release. The firm relies on subcontracted laboratories, but raw data was unavailable, and only partial HNMR spectra were reviewed, raising concerns about undetected impurities. 2. **Supplier Evaluation and Material Testing:** Absence of a system to evaluate suppliers and failure to perform identity tests on each batch of incoming raw materials ((b)(4), (b)(4), (b)(4)) used in drug production, relying solely on unverified supplier Certificates of Analysis (COAs). 3. **Raw Material Release:** The quality unit failed to evaluate recovered (b)(4) solvent for purity and quality before reuse in drug production. 4. **Product Quality Reviews:** Failure of the quality unit to conduct and document regular product quality reviews for (b)(