FEI 3002889358
FDA inspection history across 2 sites, 2018 to 2023
- 5
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2019: one Form 483; 2020: one Form 483; 2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–23Five Form 483s, at Branchburg, New Jersey and Branchbu rg, New Jersey.
- 2020The longest 483 on file: 2 observations over 6 pages at Branchburg, New Jersey.
Cited most
Across all site observations on file
- 21 CFR 211.160General requirements4
- 21 CFR 211.192Production record review4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete site file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Branchburg, New Jersey
Four Form 483s · 2018 to 2023 · 6 observations
Latest: Form 483, Jul 27, 2023 →Branchbu rg, New Jersey
One Form 483 · 2019 · 2 observations
Latest: Form 483, Nov 26, 2019 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-27 | 483 Form 483 | Branchburg, New Jersey | — | $99 |
| 2022-08-25 | 483 Form 483 | Branchburg, New Jersey | 2 | $99 |
| 2020-08-21 | 483 Form 483 | Branchburg, New Jersey | 2 | $99 |
| 2019-11-26 | 483 Form 483 | Branchbu rg, New Jersey | 2 | $99 |
| 2018-03-09 | 483 Form 483 | Branchburg, New Jersey | 2 | $99 |
Investigators on these documents
Tamil Arasu (2)Guerlain Ulysse (1)Jose O. Hernandez-Guzman (1)Kathleen M. Jordan (1)Ko U. Min (1)Nailing Zhang (1)Samuel Mindaye (1)Thuy T. Nguyen (1)Yan Wang (1)Edmund F. Mrak Jr (1)Yvesna Blaise (1)
FEI number 3002889358 · most recent document Jul 27, 2023
About FEI 3002889358
How many FDA Form 483s has FEI 3002889358 received?
FDA Intel has 5 Form 483s on file for FEI 3002889358; the most recent is dated Jul 27, 2023.
When was FEI 3002889358 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3002889358 is a Form 483 dated Jul 27, 2023, for the site in Branchburg, New Jersey.
What did FDA cite at FEI 3002889358?
The regulations cited most in the observations on file for FEI 3002889358 are 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 4 times.