FDA 483 - Armstrong Pharmaceuticals, Inc. - November 13, 2009

Armstrong Pharmaceuticals, Inc. in West Roxbury, MA, was inspected, revealing significant issues with equipment design, validation, and quality control for Epinephrine manufacturing. The inspection found unqualified equipment used for product release, failures to investigate discrepancies thoroughly, and the use of out-of-tolerance analytical balances. These observations indicate a moderate level of severity regarding quality system deficiencies.