Formatech Inc. – FDA Warning Letter, Oct 15, 2010

On February 10, 2011, the FDA issued a Warning Letter to Formatech, Inc. following an inspection from August 25 to October 15, 2010, at their clinical supply manufacturing facility in Andover, Massachusetts. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated. The firm's November 3, 2010, response was deemed insufficient.

Key violations included: 1. **Inadequate Investigations (21 CFR § 211.192):** * Failure to thoroughly investigate environmental monitoring data exceeding action limits, including insufficient assessment of disinfectant procedures and sporicidal agent use. Concerns were raised about unaddressed mold and bacteria excursions from 2008-2010, especially given manual manipulations in aseptic processing. A risk assessment for microbial and particulate contamination was inadequate, failing to address excursions near the lyophilizer or provide a plan for future investigations. * Failure to thoroughly investigate repeated heat transfer fluid leaks in the lyophilizer and their impact on product. The proposed corrective actions were inadequate, focusing only on detection rather than source correction or prevention, and failing to identify all impacted lots.

2. **Poor Facility Maintenance (21 CFR § 211.58):** Holes