FDA EIR - Argenta US Manufacturing LLC - August 01, 2019

An FDA inspection of Bayer US, LLC, located in Shawnee, Kansas, was conducted from July 22 to August 1, 2019. This comprehensive inspection assessed the company's adherence to current Good Manufacturing Practices (cGMP) for both human and animal drug products, including Active Pharmaceutical Ingredients, and readiness for commercial operations related to an Investigational New Animal Drug (INAD) application. The regulatory framework for the inspection included compliance programs for pre-approval, animal drug manufacturing, and general drug manufacturing. The inspection covered critical systems such as Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling, and Laboratory Control. At the conclusion, a two-item FDA 483: Inspectional Observations was issued. The primary findings were the extension of vendor retest dates for raw materials without sufficient scientific justification or additional testing, and the presence of not easily cleanable cracks on the aseptic barrier shield panels of the filling line in Room 1219. Bayer US, LLC management acknowledged the observations, committed to corrections, and stated they would provide a formal response to the Agency within 15 business days. The firm is registered as a manufacturer of both human and animal drugs, and medical devices. No samples were collected, and no inspection refusals occurred.