Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Form 483 issued May 3, 2019 · Andover, Massachusetts
- Inspection
- Apr 29 – May 3, 2019
- Investigators
- Amy Devlin· Gunther Bockhoudt· Nailing Zhang
- Observations
- 3
- Pages
- 4
- FEI number
- 1222181
In short: On May 3, 2019, FDA issued a Form 483 with 3 observations to Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC in Andover, Massachusetts (FEI 1222181) after an inspection that ran Apr 29 – May 3, 2019. The investigators were Amy Devlin, Gunther Bockhoudt, Nailing Zhang and Wayne Seifert. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed or are inadequate to ensure control over drug substance…
- 02
Facilities, equipment and utilities…
- 03
Corrective action to mitigate an insect incursion into Building A and Building B…
This inspection in context
Amy Devlin
4 documents · 2019–2020
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Illinois.
The firmWyeth BioPharma Division of Wyeth Pharmaceuticals LLC history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC?
Amy Devlin, Gunther Bockhoudt, Nailing Zhang and Wayne Seifert are named on this Form 483, for the inspection of Apr 29 – May 3, 2019. Each investigator has a profile showing what they cite most.
When was Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC inspected by FDA?
The inspection ran Apr 29 – May 3, 2019, and the Form 483 is dated May 3, 2019.
How do I get the full Form 483 for Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC?
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.