WuXi Biologics Co. Ltd.
FDA inspection history across 2 sites, 2019 to 2023
- 4
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2020: one Form 483; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–23Four Form 483s, at Wuxi, China and Mashan, China.
- 2023The longest 483 on file: 7 observations over 4 pages at Wuxi, China.
Cited most
Across all WuXi Biologics Co. observations on file
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.160General requirements2
- 21 CFR 211.170Reserve samples2
- 21 CFR 211.180General requirements2
The complete WuXi Biologics Co. 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
Wuxi, China
Three Form 483s · 2019 to 2023 · 15 observations
Latest: Form 483, May 9, 2023 →Mashan, China
One Form 483 · 2021 · 2 observations
Latest: Form 483, Apr 2, 2021 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-09 | 483 Form 483 | Wuxi, China | 7 | $99 |
| 2021-04-02 | 483 Form 483 | Mashan, China | 2 | $99 |
| 2020-04-16 | 483 Form 483 | Wuxi, China | 4 | $99 |
| 2019-04-16 | 483 Form 483 | Wuxi, China | 4 | $99 |
Investigators on these documents
Christopher T. Middendorf (2)Mekonnen Lemma Dechassa (2)Ramesh Potla (2)Bo Chi (1)Jonathan W. Chapman (1)Jun Liu (1)
FEI number 3010606982 · most recent document May 9, 2023
About WuXi Biologics Co. Ltd.
How many FDA Form 483s has WuXi Biologics Co. Ltd. received?
FDA Intel has 4 Form 483s on file for WuXi Biologics Co. Ltd.; the most recent is dated May 9, 2023.
When was WuXi Biologics Co. Ltd. last inspected by FDA?
The most recent FDA inspection document on file for WuXi Biologics Co. Ltd. is a Form 483 dated May 9, 2023, for the site in Wuxi, China.
What did FDA cite at WuXi Biologics Co. Ltd.?
The regulations cited most in the observations on file for WuXi Biologics Co. Ltd. are 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.160 (General requirements), 2 times.