Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
FDA inspection history in Andover, Massachusetts, 2017 to 2023
- 6
- Form 483s
- 1
- Response
- 1
- EIR
Every document, by year
- Form 483
- Response
- EIR
2017: one Form 483; 2019: three Form 483s; 2021: one 483 response, one inspection report and one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–23Six Form 483s, one 483 response and one inspection report, at Andover, Massachusetts.
- 2021The longest 483 on file: 13 observations over 5 pages at Andover, Massachusetts.
Cited most
Across all Wyeth BioPharma Division of Wyeth Pharmaceuticals observations on file
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.160General requirements3
- 21 CFR 211.56Sanitation3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
The complete Wyeth BioPharma Division of Wyeth Pharmaceuticals file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Andover, Massachusetts
Six Form 483s and one inspection report · 2017 to 2023 · 26 observations
Latest: Form 483, Sep 19, 2023 →
Also: two documents not tied to a site.
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-19 | 483 Form 483 | Andover, Massachusetts | 3 | $99 |
| 2021-08-01 | Response 483 response | — | — | $199 |
| 2021-07-23 | EIR EIR | Andover, Massachusetts | — | $550 |
| 2021-07-23 | 483 Form 483 | Andover, Massachusetts | 13 | $99 |
| 2019-05-03 | 483 Form 483 | Andover, Massachusetts | 3 | $99 |
| 2019-01-18 | 483 Form 483 | Andover, Massachusetts | 1 | $99 |
| 2019-01-17 | 483 Form 483 | Andover, Massachusetts | 2 | $99 |
| 2017-04-28 | 483 Form 483 | Andover, Massachusetts | 4 | $99 |
| Undated | other Unclassified | — | — | — |
Investigators on these documents
Debra M. Emerson (3)Ekaterina Allen (2)Anissa M. Cheung (2)Jee Y. Chung (2)Kathleen R. Jones (2)Maxwell Van Tassell (1)Nailing Zhang (1)Priscilla M. Pastrana (1)Sean R. Marcsisin (1)Aimee Cunningham (1)Wayne Seifert (1)Amy Devlin (1)
FEI number 1222181 · most recent document Sep 19, 2023
About Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
How many FDA Form 483s has Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC received?
FDA Intel has 6 Form 483s on file for Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC; the most recent is dated Sep 19, 2023.
When was Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC last inspected by FDA?
The most recent FDA inspection document on file for Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC is a Form 483 dated Sep 19, 2023, for the site in Andover, Massachusetts.
What did FDA cite at Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC?
The regulations cited most in the observations on file for Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC are 21 CFR 211.100 (Written procedures; deviations), 5 times; 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.160 (General requirements), 3 times.