FDA WARNING_LETTER - Labor L+S AG - July 21, 2011

The FDA issued a Warning Letter to Labor L+S AG following a July 18-21, 2011 inspection of their contract testing laboratory in Germany, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211). These violations render drugs tested by the facility adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's August 2, 2011 response was deemed insufficient.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate unexplained discrepancies or out-of-specification (OOS) results, such as missing environmental samples and incomplete finished product testing. Investigations for Internal Deviation Reports (e.g., 2227, 2243, 2293, 2789, 3226, 3427) concluded "inadvertently" without establishing root causes or implementing adequate corrective actions. The firm's reassessment plan for 2009-2011 deviations and OOS results was deemed inadequate due to lack of procedural description, failure to establish root cause, and lack of Quality Unit approval. The FDA requires a summary report of reassessments, customer notification evidence, specific corrective