FEI 1000526871
FDA inspection history across 2 sites, 2018 to 2020
- 3
- Form 483s
- 1
- EIR
Every document, by year
- Form 483
- EIR
2018: two Form 483s and one inspection report; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–20Three Form 483s and one inspection report, at Morris Plains, New Jersey and Morr is Plains, New Jersey.
- 2020The longest 483 on file: 10 observations over 9 pages at Morris Plains, New Jersey.
Cited most
Across all site observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.22Responsibilities of quality control unit2
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
Morris Plains, New Jersey
Two Form 483s · 2018 to 2020 · 14 observations
Latest: Form 483, Mar 10, 2020 →Morr is Plains, New Jersey
One Form 483 · 2018 · 4 observations
Latest: Form 483, Aug 1, 2018 →
Also: one document not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-03-10 | 483 Form 483 | Morris Plains, New Jersey | 10 | $99 |
| 2018-08-14 | EIR EIR | — | — | $550 |
| 2018-08-14 | 483 Form 483 | Morris Plains, New Jersey | 4 | $99 |
| 2018-08-01 | 483 Form 483 | Morr is Plains, New Jersey | 4 | $99 |
Investigators on these documents
Andrea Siegel (1)Guerlain Ulysse (1)Gunther Bockhoudt (1)Madushini Dhannasena (1)Peter R. Lenahan (1)Rajiv R. Srivastava (1)Reyes Candau-Chacon (1)Wayne Seifert (1)Willie Wilson (1)
FEI number 1000526871 · most recent document Mar 10, 2020
About FEI 1000526871
How many FDA Form 483s has FEI 1000526871 received?
FDA Intel has 3 Form 483s on file for FEI 1000526871; the most recent is dated Mar 10, 2020.
When was FEI 1000526871 last inspected by FDA?
The most recent FDA inspection document on file for FEI 1000526871 is a Form 483 dated Mar 10, 2020, for the site in Morris Plains, New Jersey.
What did FDA cite at FEI 1000526871?
The regulations cited most in the observations on file for FEI 1000526871 are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 4 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.192 (Production record review), 2 times.