AgroChem USA, LLC
FDA inspection history in Saratoga Springs, New York, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Saratoga Springs, New York.
Cited most
Across all AgroChem USA observations on file
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.170(b)Reserve samples1
- 21 CFR 211.198(b)(2)Complaint files1
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete AgroChem USA file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Saratoga Springs, New York
One Form 483 · 2023 · 5 observations
Latest: Form 483, Jan 13, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-13 | 483 Form 483 | Saratoga Springs, New York | 5 | $99 |
Investigators on these documents
FEI number 3005566735 · most recent document Jan 13, 2023
About AgroChem USA, LLC
How many FDA Form 483s has AgroChem USA, LLC received?
FDA Intel has 1 Form 483 on file for AgroChem USA, LLC; the most recent is dated Jan 13, 2023.
When was AgroChem USA, LLC last inspected by FDA?
The most recent FDA inspection document on file for AgroChem USA, LLC is a Form 483 dated Jan 13, 2023, for the site in Saratoga Springs, New York.
What did FDA cite at AgroChem USA, LLC?
The regulations cited most in the observations on file for AgroChem USA, LLC are 21 CFR 211.166(a) (Stability testing), 1 time; 21 CFR 211.170(b) (Reserve samples), 1 time; 21 CFR 211.198(b)(2) (Complaint files), 1 time.