FEI 3016774658
FDA inspection history in Clarence, New York, 2024 to 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2024–25One Form 483 and one warning letter, at Clarence, New York.
Cited most
Across all site observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(b)Stability testing1
- 21 CFR 211.188(b)Batch production and control records1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete site file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Clarence, New York
One warning letter and one Form 483 · 2024 to 2025 · 9 observations
Latest: Warning letter, Apr 7, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-07 | Warning letter Warning letter | Clarence, New York | — | $99 |
| 2024-11-08 | 483 Form 483 | Clarence, New York | 9 | $99 |
Investigators on these documents
FEI number 3016774658 · most recent document Apr 7, 2025
About FEI 3016774658
How many FDA Form 483s has FEI 3016774658 received?
FDA Intel has 1 Form 483 on file for FEI 3016774658; the most recent is dated Nov 8, 2024.
When was FEI 3016774658 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3016774658 is a Form 483 dated Nov 8, 2024, for the site in Clarence, New York.
What did FDA cite at FEI 3016774658?
The regulations cited most in the observations on file for FEI 3016774658 are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time; 21 CFR 211.166(b) (Stability testing), 1 time.
Has FEI 3016774658 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for FEI 3016774658; the most recent is dated Apr 7, 2025.