Corden Pharma SPA
FDA inspection history in Caponago, Italy, 2016 to 2018
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18Two Form 483s, at Caponago, Italy.
- 2016The longest 483 on file: 8 observations over 6 pages at Caponago, Italy.
Cited most
Across all Corden Pharma SPA observations on file
- 21 CFR 211.160General requirements6
- 21 CFR 211.192Production record review2
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.184Component, drug product container, closure, and labeling records1
The complete Corden Pharma 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
Caponago, Italy
Two Form 483s · 2016 to 2018 · 14 observations
Latest: Form 483, Jul 10, 2018 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-07-10 | 483 Form 483 | Caponago, Italy | 6 | $99 |
| 2016-07-15 | 483 Form 483 | Caponago, Italy | 8 | $99 |
Investigators on these documents
FEI number 3002880938 · most recent document Jul 10, 2018
About Corden Pharma SPA
How many FDA Form 483s has Corden Pharma SPA received?
FDA Intel has 2 Form 483s on file for Corden Pharma SPA; the most recent is dated Jul 10, 2018.
When was Corden Pharma SPA last inspected by FDA?
The most recent FDA inspection document on file for Corden Pharma SPA is a Form 483 dated Jul 10, 2018, for the site in Caponago, Italy.
What did FDA cite at Corden Pharma SPA?
The regulations cited most in the observations on file for Corden Pharma SPA are 21 CFR 211.160 (General requirements), 6 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.111 (Time limitations on production), 1 time.