Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Form 483 issued January 17, 2019 · Andover, Massachusetts
- Inspection
- Jan 4 – Jan 17, 2019
- Investigators
- Jee Y. Chung· Sean R. Marcsisin
- Observations
- 2
- Pages
- 3
- FEI number
- 1222181
In short: On January 17, 2019, FDA issued a Form 483 with 2 observations to Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC in Andover, Massachusetts (FEI 1222181) after an inspection that ran Jan 4 – Jan 17, 2019. The investigators were Jee Y. Chung and Sean R. Marcsisin. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate…
- 02
Established laboratory control mechanisms…
This inspection in context
Jee Y. Chung
5 documents · 2013–2023
Cites 211.100 (written procedures; deviations) 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 211.160
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 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC?
Jee Y. Chung and Sean R. Marcsisin are named on this Form 483, for the inspection of Jan 4 – Jan 17, 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 Jan 4 – Jan 17, 2019, and the Form 483 is dated January 17, 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.