FDA EIR - Avista Pharma Solutions, Inc. dba Cambrex - December 18, 2019

Avista Pharma Solutions, Inc. dba Cambrex, a contract testing laboratory in Agawam, MA, underwent an FDA Good Manufacturing Practice (GMP) surveillance inspection from December 9 to 18, 2019. This inspection, conducted under Compliance Program 7356.002 for Drug Manufacturing, identified two significant observations detailed in an FDA Form 483. The first observation cited failures in maintaining facilities and equipment in an appropriate state of repair, specifically noting rust and chipping paint on critical items within the sterility suite, including a floor drain cover, HVAC wall return vents, and exterior/interior surfaces of ISO-5 classified laminar flow hoods used for sterility testing of pharmaceutical products, in violation of 21 CFR 211.67(a). The second observation highlighted the quality unit's failure to adhere to established procedural timeframes for quality-related events and GMP logbook reviews, contrary to 21 CFR 211.22(d). Multiple Out of Specification (OOS) investigations and Nonconformance Investigations (NCI) exceeded their mandated completion periods without proper extension requests. Additionally, numerous GMP logbooks were not reviewed within the required timeframes. Firm management acknowledged these concerns during the close-out meeting and committed to submitting a written response to the FDA within 15 business days, outlining corrective actions for the identified issues. The inspection also included discussions on improving environmental monitoring practices and comprehensive audit trail reviews.