FDA WARNING_LETTER - Ercros S.A. - July 15, 2011

On June 20, 2012, the FDA issued a Warning Letter to Ercros S.A. following a July 11-15, 2011 inspection of their API manufacturing facility in Aranjuez, Madrid, Spain. The inspection revealed significant Current Good Manufacturing Practice (CGMP) deviations, rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's August 5, 2011, response was deemed insufficient.

Key violations include: 1. **Failure to validate the purified water system:** The system, used for a sterile API, was not properly validated until January 2010 (retrospective with limited data), despite being in use since November 2004. The validation lacked thorough assessment of critical elements, microbial, and endotoxin analysis. 2. **Failure to document complete raw data:** Specifically, endotoxin test data for purified water samples lacked complete descriptions, test methods, raw data, and signatures. This is a recurrent observation from a 2002 FDA inspection. 3. **Failure to maintain buildings and equipment:** Observations included dirt accumulation on tanks, a leaking product transfer pipe, uncleaned equipment with material buildup from prior campaigns, and a building in disrepair with openings allowing pest entry (e.g., bird feathers, spiders). 4. **