Tubilux Pharma SPA
FDA inspection history in POMEZIA, Italy, 2017 to 2020
- 1
- Close-out
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2017: one warning letter; 2019: one Form 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–20One warning letter, one Form 483 and one close-out letter, at POMEZIA, Italy.
Cited most
Across all Tubilux Pharma SPA observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.198Complaint files1
The complete Tubilux Pharma SPA 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
POMEZIA, Italy
One Form 483 and one warning letter · 2017 to 2019 · 4 observations
Latest: Form 483, Dec 10, 2019 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-03-09 | Close-out Close-out letter | — | — | $99 |
| 2019-12-10 | 483 Form 483 | POMEZIA, Italy | 4 | $99 |
| 2017-07-06 | Warning letter Warning letter | POMEZIA, Italy | — | $99 |
Investigators on these documents
FEI number 3003854110 · most recent document Mar 9, 2020
About Tubilux Pharma SPA
How many FDA Form 483s has Tubilux Pharma SPA received?
FDA Intel has 1 Form 483 on file for Tubilux Pharma SPA; the most recent is dated Dec 10, 2019.
When was Tubilux Pharma SPA last inspected by FDA?
The most recent FDA inspection document on file for Tubilux Pharma SPA is a Form 483 dated Dec 10, 2019, for the site in POMEZIA, Italy.
What did FDA cite at Tubilux Pharma SPA?
The regulations cited most in the observations on file for Tubilux Pharma SPA are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.198 (Complaint files), 1 time.
Has Tubilux Pharma SPA received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Tubilux Pharma SPA; the most recent is dated Jul 6, 2017.