The W.S. Badger Company, Inc
FDA inspection history across 2 sites, 2021 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2021: one Form 483; 2022: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Two Form 483s and one warning letter, at GILSUM, New Hampshire and Gilsum, New Hampshire.
- 2023The longest 483 on file: 11 observations over 14 pages at Gilsum, New Hampshire.
Cited most
Across all The W.S. Badger Company observations on file
- 21 CFR 211.160(a)General requirements4
- 21 CFR 211.192Production record review3
- 21 CFR 211.166(a)(3)Stability testing2
- 21 CFR 211.180(e)(2)General requirements2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
The complete The W.S. Badger Company file.
All 3 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
Gilsum, New Hampshire
One Form 483 and one warning letter · 2022 to 2023 · 11 observations
Latest: Form 483, Jun 1, 2023 →GILSUM, New Hampshire
One Form 483 · 2021 · 7 observations
Latest: Form 483, Sep 14, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-01 | 483 Form 483 | Gilsum, New Hampshire | 11 | $99 |
| 2022-04-12 | Warning letter Warning letter | Gilsum, New Hampshire | — | $99 |
| 2021-09-14 | 483 Form 483 | GILSUM, New Hampshire | 7 | $99 |
Investigators on these documents
FEI number 3009946959 · most recent document Jun 1, 2023
About The W.S. Badger Company, Inc
How many FDA Form 483s has The W.S. Badger Company, Inc received?
FDA Intel has 2 Form 483s on file for The W.S. Badger Company, Inc; the most recent is dated Jun 1, 2023.
When was The W.S. Badger Company, Inc last inspected by FDA?
The most recent FDA inspection document on file for The W.S. Badger Company, Inc is a Form 483 dated Jun 1, 2023, for the site in Gilsum, New Hampshire.
What did FDA cite at The W.S. Badger Company, Inc?
The regulations cited most in the observations on file for The W.S. Badger Company, Inc are 21 CFR 211.160(a) (General requirements), 4 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.166(a)(3) (Stability testing), 2 times.
Has The W.S. Badger Company, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for The W.S. Badger Company, Inc; the most recent is dated Apr 12, 2022.