FEI 3002808164
FDA inspection history across 2 sites, 2009 to 2018
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2009: one warning letter; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One warning letter, at Avrille Cedex, France.
- 2018One Form 483, at AVRILLE, France.
Cited most
Across all site observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
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
AVRILLE, France
One Form 483 · 2018 · 1 observation
Latest: Form 483, Oct 25, 2018 →Avrille Cedex, France
One warning letter · 2009
Latest: Warning letter, Oct 23, 2009 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-10-25 | 483 Form 483 | AVRILLE, France | 1 | $99 |
| 2009-10-23 | Warning letter Warning letter | Avrille Cedex, France | — | $99 |
Investigators on these documents
FEI number 3002808164 · most recent document Oct 25, 2018
About FEI 3002808164
How many FDA Form 483s has FEI 3002808164 received?
FDA Intel has 1 Form 483 on file for FEI 3002808164; the most recent is dated Oct 25, 2018.
When was FEI 3002808164 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3002808164 is a Form 483 dated Oct 25, 2018, for the site in AVRILLE, France.
What did FDA cite at FEI 3002808164?
The regulations cited most in the observations on file for FEI 3002808164 are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.194 (Laboratory records), 1 time; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 1 time.
Has FEI 3002808164 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for FEI 3002808164; the most recent is dated Oct 23, 2009.