Armstrong Pharmaceuticals, Inc. – FDA EIR, Nov 13, 2009

An FDA inspection of Armstrong Pharmaceuticals, Inc.'s West Roxbury, MA facility was conducted from November 2 to November 13, 2009. The inspection, part of the Drug Manufacturing Inspections Compliance Program, focused on the quality, laboratory, and equipment systems related to their Epinephrine Inhalation Aerosol (Primatene Mist) product. Six observations were issued on Form FDA 483, highlighting significant deviations from Good Manufacturing Practices. Key violations included the use of manufacturing equipment not of appropriate design or qualification, such as digital relays on a filling line causing dispensing errors, and a checkweigher failing to meet its operational qualification criteria during production. This led to the release of product batches manufactured with unqualified equipment and exceeding internal reject limits without further robust investigation or testing. Furthermore, the company failed to thoroughly review unexplained discrepancies. An Epinephrine lot with excessive rejects due to equipment malfunction was released without additional testing, and a consumer complaint regarding an out-of-specification product concentration was dismissed with a conclusion lacking documented support. Other issues noted involved instruments not meeting specifications, inadequate statistical quality control, unverified testing methods, and absent written procedures for equipment cleaning. Armstrong Pharmaceuticals committed to providing a written response to the FDA's observations within fifteen business days, outlining their corrective actions to achieve regulatory compliance.