Fareva Amboise
FDA inspection history across 2 sites, 2018 to 2026
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2018: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Poce-sur-Cisse, France.
- 2025–26One Form 483 and one warning letter, at Poce Sur Cisse, France.
- 2025The longest 483 on file: 9 observations over 16 pages at Poce Sur Cisse, France.
Cited most
Across all Fareva Amboise observations on file
- 21 CFR 211.42(a)Design and construction features3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment2
- 21 CFR 211.186(a)Master production and control records1
The complete Fareva Amboise file.
All 3 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
Poce Sur Cisse, France
One Form 483 · 2025 · 9 observations
Latest: Form 483, Sep 16, 2025 →Poce-sur-Cisse, France
One Form 483 · 2018 · 4 observations
Latest: Form 483, May 25, 2018 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-10 | Warning letter Warning letter | — | — | $99 |
| 2025-09-16 | 483 Form 483 | Poce Sur Cisse, France | 9 | $99 |
| 2018-05-25 | 483 Form 483 | Poce-sur-Cisse, France | 4 | $99 |
Investigators on these documents
Justin A. Boyd (1)Karen A. Briggs (1)Taichun Qin (1)Vivin George (1)
FEI number 3000234005 · most recent document Apr 10, 2026
About Fareva Amboise
How many FDA Form 483s has Fareva Amboise received?
FDA Intel has 2 Form 483s on file for Fareva Amboise; the most recent is dated Sep 16, 2025.
When was Fareva Amboise last inspected by FDA?
The most recent FDA inspection document on file for Fareva Amboise is a Form 483 dated Sep 16, 2025, for the site in Poce Sur Cisse, France.
What did FDA cite at Fareva Amboise?
The regulations cited most in the observations on file for Fareva Amboise are 21 CFR 211.42(a) (Design and construction features), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times.
Has Fareva Amboise received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Fareva Amboise; the most recent is dated Apr 10, 2026.