Wyeth Pharmaceutical, Div Wyeth Holding Corp.
FDA inspection history in Pearl River, New York, 2008 to 2022
- 3
- Form 483s
- 1
- EIR
Every document, by year
- Form 483
- EIR
2008: one inspection report and one Form 483; 2017: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2008One inspection report and one Form 483, at Pearl River, New York.
- 2017One Form 483, at Pearl River, New York.
- 2022One Form 483, at Pearl River, New York.
- 2022The longest 483 on file: 11 observations over 19 pages at Pearl River, New York.
Cited most
Across all Wyeth Pharmaceutical, Div Wyeth Holding observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.160General requirements3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 111.320What requirements apply to laboratory methods for testing and examination?2
- 21 CFR 211.192Production record review2
The complete Wyeth Pharmaceutical, Div Wyeth Holding file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Pearl River, New York
Three Form 483s and one inspection report · 2008 to 2022 · 24 observations
Latest: Form 483, Apr 13, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-04-13 | 483 Form 483 | Pearl River, New York | 11 | $99 |
| 2017-03-17 | 483 Form 483 | Pearl River, New York | 7 | $99 |
| 2008-10-08 | EIR EIR | Pearl River, New York | — | $550 |
| 2008-10-08 | 483 Form 483 | Pearl River, New York | 6 | $99 |
Investigators on these documents
Antonina Aydanian (1)Charles Jewell (1)Diane Raccasi (1)J. W. Unknown (1)Jacqueline S. Warner (1)Kristina L. Conroy (1)Lata Mathew (1)Maria J. Lopez-Barragan (1)Marjorie A. Shapiro (1)Mate Tolnay (1)Wayne Seifert (1)Yvins Dezan (1)
FEI number 2410662 · most recent document Apr 13, 2022
About Wyeth Pharmaceutical, Div Wyeth Holding Corp.
How many FDA Form 483s has Wyeth Pharmaceutical, Div Wyeth Holding Corp. received?
FDA Intel has 3 Form 483s on file for Wyeth Pharmaceutical, Div Wyeth Holding Corp.; the most recent is dated Apr 13, 2022.
When was Wyeth Pharmaceutical, Div Wyeth Holding Corp. last inspected by FDA?
The most recent FDA inspection document on file for Wyeth Pharmaceutical, Div Wyeth Holding Corp. is a Form 483 dated Apr 13, 2022, for the site in Pearl River, New York.
What did FDA cite at Wyeth Pharmaceutical, Div Wyeth Holding Corp.?
The regulations cited most in the observations on file for Wyeth Pharmaceutical, Div Wyeth Holding Corp. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times.