FDA 483 - AgroChem USA, LLC - January 13, 2023

AgroChem USA, LLC, an animal drug manufacturer in Saratoga Springs, NY, was inspected by the FDA and received a Form 483. The inspection revealed significant deficiencies across multiple areas, including data integrity, quality control for reserve samples and stability testing, raw material testing, and complaint handling. These issues indicate a lack of appropriate controls and documentation for critical manufacturing processes.