Cambrex Profarmaco Milano SRL
FDA inspection history in MILANO, Italy, 2009 to 2017
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2009: one warning letter; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One warning letter.
- 2017One Form 483, at MILANO, Italy.
Cited most
Across all Cambrex Profarmaco Milano SRL observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.58Maintenance1
The complete Cambrex Profarmaco Milano SRL 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
MILANO, Italy
One Form 483 · 2017 · 8 observations
Latest: Form 483, May 19, 2017 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-05-19 | 483 Form 483 | MILANO, Italy | 8 | $99 |
| 2009-08-12 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
FEI number 3003723076 · most recent document May 19, 2017
About Cambrex Profarmaco Milano SRL
How many FDA Form 483s has Cambrex Profarmaco Milano SRL received?
FDA Intel has 1 Form 483 on file for Cambrex Profarmaco Milano SRL; the most recent is dated May 19, 2017.
When was Cambrex Profarmaco Milano SRL last inspected by FDA?
The most recent FDA inspection document on file for Cambrex Profarmaco Milano SRL is a Form 483 dated May 19, 2017, for the site in MILANO, Italy.
What did FDA cite at Cambrex Profarmaco Milano SRL?
The regulations cited most in the observations on file for Cambrex Profarmaco Milano SRL are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Cambrex Profarmaco Milano SRL received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Cambrex Profarmaco Milano SRL; the most recent is dated Aug 12, 2009.