Intercos Europe SPA
FDA inspection history in Agrate Brianza, Italy, 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One warning letter and one Form 483, at Agrate Brianza, Italy.
Cited most
Across all Intercos Europe SPA observations on file
- 21 CFR 211.84(b)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.192Production record review1
- 21 CFR 211.194(a)Laboratory records1
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
The complete Intercos Europe 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
Agrate Brianza, Italy
One warning letter and one Form 483 · 2024 · 5 observations
Latest: Warning letter, Aug 15, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-15 | Warning letter Warning letter | Agrate Brianza, Italy | — | $99 |
| 2024-03-15 | 483 Form 483 | Agrate Brianza, Italy | 5 | $99 |
Investigators on these documents
FEI number 1000181428 · most recent document Aug 15, 2024
About Intercos Europe SPA
How many FDA Form 483s has Intercos Europe SPA received?
FDA Intel has 1 Form 483 on file for Intercos Europe SPA; the most recent is dated Mar 15, 2024.
When was Intercos Europe SPA last inspected by FDA?
The most recent FDA inspection document on file for Intercos Europe SPA is a Form 483 dated Mar 15, 2024, for the site in Agrate Brianza, Italy.
What did FDA cite at Intercos Europe SPA?
The regulations cited most in the observations on file for Intercos Europe SPA are 21 CFR 211.84(b) (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.194(a) (Laboratory records), 1 time.
Has Intercos Europe SPA received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Intercos Europe SPA; the most recent is dated Aug 15, 2024.