Astrea Monts
FDA inspection history in Monts, France, 2013 to 2022
- 4
- Form 483s
Every document, by year
- Form 483
2013: one Form 483; 2015: one Form 483; 2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–15Two Form 483s, at Monts, France.
- 2019One Form 483, at Monts, France.
- 2022One Form 483, at Monts, France.
- 2022The longest 483 on file: 10 observations over 6 pages at Monts, France.
Cited most
Across all Astrea Monts observations on file
- 21 CFR 211.42(c)(10)(ii)Design and construction features3
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Astrea Monts 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
Monts, France
Four Form 483s · 2013 to 2022 · 19 observations
Latest: Form 483, Oct 18, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-10-18 | 483 Form 483 | Monts, France | 10 | $99 |
| 2019-11-12 | 483 Form 483 | Monts, France | 1 | $99 |
| 2015-06-09 | 483 Form 483 | Monts, France | 3 | $99 |
| 2013-02-26 | 483 Form 483 | Monts, France | 5 | $99 |
Investigators on these documents
Christopher Keating (1)Michael E. Maselli (1)Nadeem I. Chaudhry (1)S. Lori Brown (1)Sandra A. Boyd (1)
FEI number 1000171152 · most recent document Oct 18, 2022
About Astrea Monts
How many FDA Form 483s has Astrea Monts received?
FDA Intel has 4 Form 483s on file for Astrea Monts; the most recent is dated Oct 18, 2022.
When was Astrea Monts last inspected by FDA?
The most recent FDA inspection document on file for Astrea Monts is a Form 483 dated Oct 18, 2022, for the site in Monts, France.
What did FDA cite at Astrea Monts?
The regulations cited most in the observations on file for Astrea Monts are 21 CFR 211.42(c)(10)(ii) (Design and construction features), 3 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.166 (Stability testing), 2 times.