Avista Pharma Solutions, Inc. – FDA EIR, Jul 25, 2025

An FDA surveillance inspection of Avista Pharma Solutions, Inc., operating as Cambrex, in Agawam, MA, was conducted from July 22-25, 2025. This inspection, performed under Compliance Program 7356.002 for Drug Manufacturing, identified five significant deficiencies, indicating a recurrence of previous quality control issues.

Key violations included a failure to thoroughly investigate an environmental monitoring excursion in the ISO-6 sterility testing room, impacting product safety and purity (21 CFR 211.192). The facility was found not to be maintained in a clean and sanitary condition, with observations of residue and deteriorating labels in critical cleanroom areas (21 CFR 211.56(a)). Furthermore, the building was not in a good state of repair, evidenced by paint chipping and degrading pipelines in utility areas impacting cleanroom air systems (21 CFR 211.58). The quality control unit failed to consistently follow its own procedures, specifically regarding the timely approval of environmental monitoring data (21 CFR 211.22(d)). Lastly, inadequate controls over computer systems allowed an analyst-level account to modify system date/time and delete original data, raising data integrity concerns.

In response to the Form FDA-483 Inspectional Observations, company management committed to submitting a written reply within 15 business days addressing these critical findings.