483
AgroChem USA, LLCFDA 483 - AgroChem USA, LLC - January 13, 2023
Record Details
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.
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ID · a49443c1-a080-4f88-ab2c-4c509fedf727