Moehs Cantabra, S.L. – FDA Warning Letter, Dec 17, 2010

This FDA Warning Letter, dated April 14, 2011, addresses Moehs Cantabra, S.L. following a December 13-17, 2010 inspection of their API manufacturing facility in Polanco Cantabria, Spain. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP), rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's January 14, 2011, response was deemed insufficient.

Key violations include: 1. **Failure to investigate and document out-of-specification (OOS) results:** Specifically, an (b)(4) API lot was released based on a passing retest without investigation after an initial OOS assay result. The firm's justification lacked scientific support. 2. **Failure to follow approved test procedures:** The firm did not adhere to the required HPLC injection sequence for (b)(4) and (b)(4) assays, and not all injection results were reported for certain lots. 3. **Incomplete and unreliable laboratory control records:** Raw data for sample and standard weights were missing, with only Excel spreadsheets available. Some HPLC chromatographs were also absent from batch records. 4. **Inadequate product quality reviews:** The 2008 annual product review for (b)(4) contained discrepancies between reported impurity levels