Wyeth Lederle S.r.l
Form 483 issued April 20, 2017 · Catania, Italy
- Inspection
- Apr 10 – Apr 20, 2017
- Investigators
- David J. Gomes· Junho Pak
- Observations
- 1
- Pages
- 4
- FEI number
- 3002806766
In short: On April 20, 2017, FDA issued a Form 483 with 1 observation to Wyeth Lederle S.r.l in Catania, Italy (FEI 3002806766) after an inspection that ran Apr 10 – Apr 20, 2017. The investigators were David J. Gomes and Junho Pak. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42(c)(10)(iv) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
This inspection in context
David J. Gomes
3 documents · 2017–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Italy.
The firmWyeth Lederle S.r.l history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wyeth Lederle S.r.l?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Wyeth Lederle S.r.l?
David J. Gomes and Junho Pak are named on this Form 483, for the inspection of Apr 10 – Apr 20, 2017. Each investigator has a profile showing what they cite most.
When was Wyeth Lederle S.r.l inspected by FDA?
The inspection ran Apr 10 – Apr 20, 2017, and the Form 483 is dated April 20, 2017.
How do I get the full Form 483 for Wyeth Lederle S.r.l?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.