Bushu Pharmaceuticals Ltd.
FDA inspection history in Kawagoe, Japan, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Kawagoe, Japan.
Cited most
Across all Bushu Pharmaceuticals observations on file
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.42(c)Design and construction features1
The complete Bushu Pharmaceuticals file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Kawagoe, Japan
One Form 483 · 2022 · 3 observations
Latest: Form 483, Dec 2, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-02 | 483 Form 483 | Kawagoe, Japan | 3 | $99 |
Investigators on these documents
FEI number 3005709762 · most recent document Dec 2, 2022
About Bushu Pharmaceuticals Ltd.
How many FDA Form 483s has Bushu Pharmaceuticals Ltd. received?
FDA Intel has 1 Form 483 on file for Bushu Pharmaceuticals Ltd.; the most recent is dated Dec 2, 2022.
When was Bushu Pharmaceuticals Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Bushu Pharmaceuticals Ltd. is a Form 483 dated Dec 2, 2022, for the site in Kawagoe, Japan.
What did FDA cite at Bushu Pharmaceuticals Ltd.?
The regulations cited most in the observations on file for Bushu Pharmaceuticals Ltd. are 21 CFR 211.160(a) (General requirements), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time; 21 CFR 211.42(c) (Design and construction features), 1 time.