Ningbo Smart Pharmaceutical Co. Ltd. – FDA Warning Letter, Oct 29, 2010

On March 30, 2011, the FDA issued a Warning Letter to Ningbo Smart Pharmaceutical Co. Ltd. following an October 25-29, 2010 inspection of their API manufacturing facility in Ningbo, China. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP), rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations included: 1. **Failure of the Quality Control Unit (QCU) to ensure appropriate material testing and reporting:** The QCU approved API batches for release (e.g., (b)(4) USP) without performing required Organic Volatile Impurity (OVI) testing, despite Certificates of Analysis stating conformance. The firm's November 19, 2010 response was deemed insufficient, requiring a comprehensive retrospective review of analytical data and batch records for all products within expiration, and a plan to prevent recurrence, including expanded investigation to all products and comprehensive training. 2. **Failure of the QCU to ensure CGMP compliance and meet specifications:** The QCU released API lots to the U.S. without all required tests, failing to detect inaccurate OVI reporting. Specifically, (b)(4) USP batch #(b)(4) was released without OVI testing, which is required by DMF (b)(4). The firm's explanation of discontinuing OVI