Dr. Reddys de Mexico – FDA Warning Letter, Nov 11, 2010

On June 3, 2011, the FDA issued a Warning Letter to Dr. Reddy's Laboratories Limited, specifically addressing their API manufacturing facility, Industrias Quimicas Falcon de Mexico, S.A. de C.V. (Dr. Reddy’s Mexico). This letter followed an inspection conducted from November 8-11, 2010, which revealed significant deviations from Current Good Manufacturing Practice (CGMP) for APIs, rendering their products adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Unvalidated Analytical Methods:** The firm failed to validate analytical methods for testing APIs, including the HPLC method for assay and related substances of (b)(4) (finished API (b)(4) for human use). While the firm committed to validate non-compendial methods by April 30, 2011, and verify compendial methods by June 30, 2011, the FDA expressed concern about products already on the market tested with unvalidated methods. The FDA requested a plan to prevent adulterated API from reaching the U.S. market and actions for adulterated API already on the market. 2. **Incomplete Cleaning Validation:** Cleaning validation for non-dedicated manufacturing equipment was incomplete, with specific examples in Bay 2. The FDA was concerned about potential cross