FDA EIR - Curia New York, Inc. - November 09, 2017

An FDA Good Manufacturing Practice (GMP) inspection of AMRI Rensselaer, Inc. in Rensselaer, NY, was conducted from November 6-9, 2017. The inspection, performed under Compliance Program 7356.002F and the ICH-Q7 guideline for Active Pharmaceutical Ingredient (API) manufacturing, identified two significant observations documented on an FDA Form 483. The primary violation included the absence of established and validated written procedures for cleaning specific manufacturing equipment used in the production of intermediates and APIs. The second major issue concerned the company's computerized systems in the Quality Control Laboratory, specifically a particle size analyzer. These systems lacked sufficient controls to prevent unauthorized changes or deletions to electronically generated raw data and failed to adequately identify the persons making such changes through an audit trail. Management acknowledged both observations and stated their commitment to correcting these issues. They also committed to submitting a written response to the FDA within 15 business days, outlining their corrective actions. No samples were collected, and no refusals were encountered during the inspection.