BrightGene Fine Chemical Co., Ltd.
FDA inspection history in Taizhou, China, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Taizhou, China.
Cited most
Across all BrightGene Fine Chemical Co. observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete BrightGene Fine Chemical Co. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Taizhou, China
One Form 483 · 2024
Latest: Form 483, Jan 20, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-01-20 | 483 Form 483 | Taizhou, China | — | $99 |
FEI number 3011254184 · most recent document Jan 20, 2024
About BrightGene Fine Chemical Co., Ltd.
How many FDA Form 483s has BrightGene Fine Chemical Co., Ltd. received?
FDA Intel has 1 Form 483 on file for BrightGene Fine Chemical Co., Ltd.; the most recent is dated Jan 20, 2024.
When was BrightGene Fine Chemical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for BrightGene Fine Chemical Co., Ltd. is a Form 483 dated Jan 20, 2024, for the site in Taizhou, China.
What did FDA cite at BrightGene Fine Chemical Co., Ltd.?
The regulations cited most in the observations on file for BrightGene Fine Chemical Co., Ltd. are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.