FEI 1972829
FDA inspection history across 2 sites, 2014 to 2025
- 6
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2017: one Form 483; 2019: one Form 483; 2021: one Form 483; 2024: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One Form 483, at Fenton, Missouri.
- 2017–21Three Form 483s, at Fenton, Missouri.
- 2024–25Two Form 483s, at Fenton, Missouri and Saint Louis, Missouri.
- 2024The longest 483 on file: 10 observations over 11 pages at Fenton, Missouri.
Cited most
Across all site observations on file
- 21 CFR 211.42Design and construction features8
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.192Production record review4
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.67Equipment cleaning and maintenance3
The complete site file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Fenton, Missouri
Five Form 483s · 2014 to 2024 · 38 observations
Latest: Form 483, Feb 8, 2024 →Saint Louis, Missouri
One Form 483 · 2025 · 8 observations
Latest: Form 483, Sep 23, 2025 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-23 | 483 Form 483 | Saint Louis, Missouri | 8 | $99 |
| 2024-02-08 | 483 Form 483 | Fenton, Missouri | 10 | $99 |
| 2021-09-28 | 483 Form 483 | Fenton, Missouri | 4 | $99 |
| 2019-08-28 | 483 Form 483 | Fenton, Missouri | 8 | $99 |
| 2017-11-16 | 483 Form 483 | Fenton, Missouri | 6 | $99 |
| 2014-08-14 | 483 Form 483 | Fenton, Missouri | 10 | $99 |
Investigators on these documents
June P. Page (1)Lisa L. Flores (1)Mindy M. Chou (1)Robert J. Ham (1)Sarah M. Gauna (1)Shirley J. Berryman (1)Tiara N. Brown-Crosen (1)Wayne D. McGrath (1)
FEI number 1972829 · most recent document Sep 23, 2025
About FEI 1972829
How many FDA Form 483s has FEI 1972829 received?
FDA Intel has 6 Form 483s on file for FEI 1972829; the most recent is dated Sep 23, 2025.
When was FEI 1972829 last inspected by FDA?
The most recent FDA inspection document on file for FEI 1972829 is a Form 483 dated Sep 23, 2025, for the site in Saint Louis, Missouri.
What did FDA cite at FEI 1972829?
The regulations cited most in the observations on file for FEI 1972829 are 21 CFR 211.42 (Design and construction features), 8 times; 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.192 (Production record review), 4 times.