AgroChem USA, LLC
Form 483 issued January 13, 2023 · Saratoga Springs, New York
- Inspection
- Jan 9 – Jan 13, 2023
- Investigator
- Tanya R. Syffrard
- Observations
- 5
- Pages
- 4
- FEI number
- 3005566735
In short: On January 13, 2023, FDA issued a Form 483 with 5 observations to AgroChem USA, LLC in Saratoga Springs, New York (FEI 3005566735) after an inspection that ran Jan 9 – Jan 13, 2023. The investigator was Tanya R. Syffrard. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
- 03
There is no written testing program designed to assess the stability…
- 04
Each component is not tested for conformity with all appropriate written specifications for…
This inspection in context
Tanya R. Syffrard
11 documents · 2021–2025
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmAgroChem USA, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AgroChem USA, LLC?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected AgroChem USA, LLC?
Tanya R. Syffrard is named on this Form 483, for the inspection of Jan 9 – Jan 13, 2023. Each investigator has a profile showing what they cite most.
When was AgroChem USA, LLC inspected by FDA?
The inspection ran Jan 9 – Jan 13, 2023, and the Form 483 is dated January 13, 2023.
How do I get the full Form 483 for AgroChem USA, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.