FAREVA Unterach GmbH
FDA inspection history in Unterach am Attersee, Austria, 2013 to 2019
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2013: one warning letter; 2015: one close-out letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–15One warning letter and one close-out letter, at Unterach am Attersee, Austria.
- 2019One Form 483, at Unterach am Attersee, Austria.
Cited most
Across all FAREVA Unterach observations on file
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166(a)Stability testing1
The complete FAREVA Unterach 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
Unterach am Attersee, Austria
One Form 483 and one warning letter · 2013 to 2019 · 2 observations
Latest: Form 483, May 8, 2019 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-05-08 | 483 Form 483 | Unterach am Attersee, Austria | 2 | $99 |
| 2015-09-14 | Close-out Close-out letter | — | — | $99 |
| 2013-05-28 | Warning letter Warning letter | Unterach am Attersee, Austria | — | $99 |
Investigators on these documents
FEI number 3002829723 · most recent document May 8, 2019
About FAREVA Unterach GmbH
How many FDA Form 483s has FAREVA Unterach GmbH received?
FDA Intel has 1 Form 483 on file for FAREVA Unterach GmbH; the most recent is dated May 8, 2019.
When was FAREVA Unterach GmbH last inspected by FDA?
The most recent FDA inspection document on file for FAREVA Unterach GmbH is a Form 483 dated May 8, 2019, for the site in Unterach am Attersee, Austria.
What did FDA cite at FAREVA Unterach GmbH?
The regulations cited most in the observations on file for FAREVA Unterach GmbH are 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.
Has FAREVA Unterach GmbH received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for FAREVA Unterach GmbH; the most recent is dated May 28, 2013.