ACS Dobfar SPA
FDA inspection history in Tribiano, Italy, 2005 to 2017
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2005: one warning letter; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2005One warning letter, at Tribiano, Italy.
- 2017One Form 483, at Tribiano, Italy.
Cited most
Across all ACS Dobfar SPA observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.42Design and construction features1
The complete ACS Dobfar SPA 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
Tribiano, Italy
One Form 483 and one warning letter · 2005 to 2017 · 3 observations
Latest: Form 483, Jul 18, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-07-18 | 483 Form 483 | Tribiano, Italy | 3 | $99 |
| 2005-07-21 | Warning letter Warning letter | Tribiano, Italy | — | $99 |
Investigators on these documents
FEI number 3002806297 · most recent document Jul 18, 2017
About ACS Dobfar SPA
How many FDA Form 483s has ACS Dobfar SPA received?
FDA Intel has 1 Form 483 on file for ACS Dobfar SPA; the most recent is dated Jul 18, 2017.
When was ACS Dobfar SPA last inspected by FDA?
The most recent FDA inspection document on file for ACS Dobfar SPA is a Form 483 dated Jul 18, 2017, for the site in Tribiano, Italy.
What did FDA cite at ACS Dobfar SPA?
The regulations cited most in the observations on file for ACS Dobfar SPA are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.42 (Design and construction features), 1 time.
Has ACS Dobfar SPA received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for ACS Dobfar SPA; the most recent is dated Jul 21, 2005.