Wyeth Pharmaceutical, Div Wyeth Holding Corp.
Form 483 issued April 13, 2022 · Pearl River, New York
- Inspection
- Mar 7 – Apr 13, 2022
- Investigators
- Kristina L. Conroy· Lata Mathew· Yvins Dezan
- Observations
- 11
- Pages
- 19
- FEI number
- 2410662
In short: On April 13, 2022, FDA issued a Form 483 with 11 observations to Wyeth Pharmaceutical, Div Wyeth Holding Corp. in Pearl River, New York (FEI 2410662) after an inspection that ran Mar 7 – Apr 13, 2022. The investigators were Kristina L. Conroy, Lata Mathew and Yvins Dezan. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 7 of 11 observations.
Most cited: 21 CFR 211.192 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Kristina L. Conroy
10 documents · 2021–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmWyeth Pharmaceutical, Div Wyeth Holding Corp. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wyeth Pharmaceutical, Div Wyeth Holding Corp.?
FDA listed 11 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Wyeth Pharmaceutical, Div Wyeth Holding Corp.?
Kristina L. Conroy, Lata Mathew and Yvins Dezan are named on this Form 483, for the inspection of Mar 7 – Apr 13, 2022. Each investigator has a profile showing what they cite most.
When was Wyeth Pharmaceutical, Div Wyeth Holding Corp. inspected by FDA?
The inspection ran Mar 7 – Apr 13, 2022, and the Form 483 is dated April 13, 2022.
How do I get the full Form 483 for Wyeth Pharmaceutical, Div Wyeth Holding Corp.?
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.