Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Form 483 issued September 19, 2023 · Andover, Massachusetts
- Inspection
- Sep 6 – Sep 19, 2023
- Investigators
- Brentley Collins· Gene D. Arcy· Priscilla M. Pastrana
- Observations
- 3
- Pages
- 4
- FEI number
- 1222181
In short: On September 19, 2023, 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 Sep 6 – Sep 19, 2023. The investigators were Brentley Collins, Gene D. Arcy and Priscilla M. Pastrana. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×) · 211.110 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Your firm's designation of (b) (4) as a "non-CQA" is not justified based, in part, on…
This inspection in context
Brentley Collins
11 documents · 2019–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
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 production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC?
Brentley Collins, Gene D. Arcy and Priscilla M. Pastrana are named on this Form 483, for the inspection of Sep 6 – Sep 19, 2023. 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 Sep 6 – Sep 19, 2023, and the Form 483 is dated September 19, 2023.
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.