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

Source: https://www.globalkeysolutions.net/records/483/agrochem-usa-llc/a49443c1-a080-4f88-ab2c-4c509fedf727

> FDA 483 for AgroChem USA, LLC on January 13, 2023. Product: veterinary. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: AgroChem USA, LLC
- Inspection Date: 2023-01-13
- Product Type: veterinary
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Officers

- [Tanya R. Syffrard](https://www.globalkeysolutions.net/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)

Company: https://www.globalkeysolutions.net/companies/agrochem-usa-llc/007b3455-bf3c-4d23-b1e7-0be79ebba21e

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961