Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Form 483 issued January 18, 2019 · Andover, Massachusetts
- Inspection
- Jan 14 – Jan 18, 2019
- Investigators
- Aimee Cunningham· Jee Y. Chung· Maxwell Van Tassell
- Observations
- 1
- Pages
- 1
- FEI number
- 1222181
In short: On January 18, 2019, FDA issued a Form 483 with 1 observation to Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC in Andover, Massachusetts (FEI 1222181) after an inspection that ran Jan 14 – Jan 18, 2019. The investigators were Aimee Cunningham, Jee Y. Chung and Maxwell Van Tassell. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Critical materials and reagents used for release and stability testing of the drug substance and drug…
This inspection in context
Aimee Cunningham
2 documents · 2017–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Japan.
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 1 observation 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?
Aimee Cunningham, Jee Y. Chung and Maxwell Van Tassell are named on this Form 483, for the inspection of Jan 14 – Jan 18, 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 14 – Jan 18, 2019, and the Form 483 is dated January 18, 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.