Latina Pharma S.P.A
FDA inspection history in Sermoneta, Italy, 2016 to 2017
- 1
- Close-out
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2016: one warning letter; 2017: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17One warning letter, one close-out letter and one Form 483, at Sermoneta, Italy.
Cited most
Across all Latina Pharma S.P.A observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.115Reprocessing1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.176Penicillin contamination1
- 21 CFR 211.188Batch production and control records1
The complete Latina Pharma S.P.A 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
Sermoneta, Italy
One Form 483 and one warning letter · 2016 to 2017 · 6 observations
Latest: Form 483, Apr 21, 2017 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-08-17 | Close-out Close-out letter | — | — | $99 |
| 2017-04-21 | 483 Form 483 | Sermoneta, Italy | 6 | $99 |
| 2016-05-20 | Warning letter Warning letter | Sermoneta, Italy | — | $99 |
Investigators on these documents
FEI number 3001229385 · most recent document Aug 17, 2017
About Latina Pharma S.P.A
How many FDA Form 483s has Latina Pharma S.P.A received?
FDA Intel has 1 Form 483 on file for Latina Pharma S.P.A; the most recent is dated Apr 21, 2017.
When was Latina Pharma S.P.A last inspected by FDA?
The most recent FDA inspection document on file for Latina Pharma S.P.A is a Form 483 dated Apr 21, 2017, for the site in Sermoneta, Italy.
What did FDA cite at Latina Pharma S.P.A?
The regulations cited most in the observations on file for Latina Pharma S.P.A are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.115 (Reprocessing), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.
Has Latina Pharma S.P.A received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Latina Pharma S.P.A; the most recent is dated May 20, 2016.