Wyeth Lederle S.r.l
FDA inspection history in Catania, Italy, 2012 to 2017
- 1
- Close-out
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2012: 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.
- 2012One warning letter, at Catania, Italy.
- 2017One close-out letter and one Form 483, at Catania, Italy.
Cited most
Across all Wyeth Lederle S.r.l observations on file
- 21 CFR 211.42(c)(10)(iv)Design and construction features1
The complete Wyeth Lederle S.r.l 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
Catania, Italy
One Form 483 and one warning letter · 2012 to 2017 · 1 observation
Latest: Form 483, Apr 20, 2017 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-09-18 | Close-out Close-out letter | — | — | $99 |
| 2017-04-20 | 483 Form 483 | Catania, Italy | 1 | $99 |
| 2012-07-09 | Warning letter Warning letter | Catania, Italy | — | $99 |
Investigators on these documents
FEI number 3002806766 · most recent document Sep 18, 2017
About Wyeth Lederle S.r.l
How many FDA Form 483s has Wyeth Lederle S.r.l received?
FDA Intel has 1 Form 483 on file for Wyeth Lederle S.r.l; the most recent is dated Apr 20, 2017.
When was Wyeth Lederle S.r.l last inspected by FDA?
The most recent FDA inspection document on file for Wyeth Lederle S.r.l is a Form 483 dated Apr 20, 2017, for the site in Catania, Italy.
What did FDA cite at Wyeth Lederle S.r.l?
The regulations cited most in the observations on file for Wyeth Lederle S.r.l are 21 CFR 211.42(c)(10)(iv) (Design and construction features), 1 time.
Has Wyeth Lederle S.r.l received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Wyeth Lederle S.r.l; the most recent is dated Jul 9, 2012.