FDA WARNING_LETTER - Teva Pharmaceutical Industries - September 16, 2010

The FDA issued a Warning Letter to Teva Pharmaceutical Industries, Ltd. following a September 12-16, 2010 inspection of their Jerusalem, Israel facility, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211). These violations render their drug products adulterated.

Key violations include: 1. **Inadequate Investigations of Out-of-Specification (OOS) Results (21 CFR § 211.192):** * Failure to thoroughly investigate OOS results for drug products, including insufficient justification for invalidating original results and relying on retest results without confirmed root causes of failure (e.g., for lot #(b)(4) of (b)(4) mg (b)(4) mg, and lot #(b)(4) of (b)(4) tablets (b)(4) mg). * Failure to identify the source of black particles found in a sample powder for lot #(b)(4) of (b)(4) mg/ (b)(4) mg, and to determine if other lots were affected. * Lack of thorough evaluation of manufacturing processes and other potentially affected lots before invalidating OOS results. * Concerns about the release of finished drug batches to the U.S. market with scientifically unsound OOS investigations.

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