FDA WARNING_LETTER - Hikma Farmaceutica, (Portugal) S.A. - March 28, 2014

The FDA issued a Warning Letter to Hikma Farmaceutica, (Portugal) S.A. following a March 20-28, 2014 inspection, identifying significant violations of CGMP regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated. The firm's April 16, 2014 response and subsequent correspondences were deemed insufficient.

Key violations include: 1. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** The firm failed to adequately investigate 23 environmental monitoring (EM) excursions in Class 100 aseptic areas from January 2012 to December 2013. Investigations cited "possible root causes" like mishandling/poor aseptic technique but couldn't determine actual root causes, disregarding excursions without justification and failing to assess product impact. The proposed corrective action of improving EM plate preparation was rejected as unsupported. Concerns were raised about pre-incubation of EM media plates potentially compromising growth promotion. This is a repeat violation from 2004, 2007, and 2011 inspections. 2. **Inadequate written procedures for production and process control (21 CFR 211.100(a)):** The firm failed to provide adequate challenge test vials for qualifying operators and QA staff for visual inspection. 14 of