FDA WARNING_LETTER - Jenahexal Pharm GmbH - October 29, 2010

The FDA issued a Warning Letter to Jenahexal Pharm GmbH following an October 25-29, 2010 inspection of their German pharmaceutical manufacturing facility, identifying significant Current Good Manufacturing Practice (CGMP) violations for Finished Pharmaceuticals (21 CFR Parts 210 and 211). These violations render their drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's November 26, 2010, response to the FDA 483 was deemed insufficient.

Key violations include: 1. Failure to establish appropriate written testing procedures for sterile drug products, specifically lacking bacterial endotoxin testing for homeopathic injectables distributed in the U.S. (21 CFR §211.167(a)). 2. Inadequate validation of analytical methods, such as sterility test methods, lacking verification of bacteriostasis and fungistatis activity (21 CFR §211.165(e)). 3. Absence of a written assessment of stability for homeopathic drug products, despite the requirement for evidence of stability over expected shelf life (21 CFR §211.166(c)(1)). 4. Failure to test each component for conformity with written specifications, exemplified by not testing incoming (b)(4) solution for identity before use (21 CFR §211.