FEI 3014307835
FDA inspection history in Phoenix, Arizona, 2022 to 2025
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2022: one Form 483; 2023: one Form 483; 2024: one warning letter; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–25Three Form 483s and one warning letter, at Phoenix, Arizona.
- 2023The longest 483 on file: 17 observations over 28 pages at Phoenix, Arizona.
Cited most
Across all site observations on file
- 21 CFR 211.192Production record review5
- 21 CFR 211.42(c)(10)(iv)Design and construction features4
- 21 CFR 211.160(a)General requirements3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.113(b)Control of microbiological contamination2
The complete site file.
All 4 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
Phoenix, Arizona
Three Form 483s and one warning letter · 2022 to 2025 · 31 observations
Latest: Form 483, Sep 5, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-05 | 483 Form 483 | Phoenix, Arizona | 8 | $99 |
| 2024-03-25 | Warning letter Warning letter | Phoenix, Arizona | — | $99 |
| 2023-07-31 | 483 Form 483 | Phoenix, Arizona | 17 | $99 |
| 2022-02-25 | 483 Form 483 | Phoenix, Arizona | 6 | $99 |
Investigators on these documents
Christopher M. Jenner (1)Dogbeda F. Mackenzie (1)Gunneet Kaur (1)Homero W. Aguilar (1)June P. Page (1)Roger F. Zabinski (1)
FEI number 3014307835 · most recent document Sep 5, 2025
About FEI 3014307835
How many FDA Form 483s has FEI 3014307835 received?
FDA Intel has 3 Form 483s on file for FEI 3014307835; the most recent is dated Sep 5, 2025.
When was FEI 3014307835 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3014307835 is a Form 483 dated Sep 5, 2025, for the site in Phoenix, Arizona.
What did FDA cite at FEI 3014307835?
The regulations cited most in the observations on file for FEI 3014307835 are 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.42(c)(10)(iv) (Design and construction features), 4 times; 21 CFR 211.160(a) (General requirements), 3 times.
Has FEI 3014307835 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for FEI 3014307835; the most recent is dated Mar 25, 2024.