Jiangsu Grand Xinyi Pharmaceutical Co., Ltd.
FDA inspection history in Yancheng, China, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Yancheng, China.
Cited most
Across all Jiangsu Grand Xinyi Pharmaceutical Co. observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.48Plumbing1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Jiangsu Grand Xinyi Pharmaceutical Co. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Yancheng, China
One Form 483 · 2019 · 6 observations
Latest: Form 483, Sep 12, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-09-12 | 483 Form 483 | Yancheng, China | 6 | $99 |
Investigators on these documents
FEI number 3011070603 · most recent document Sep 12, 2019
About Jiangsu Grand Xinyi Pharmaceutical Co., Ltd.
How many FDA Form 483s has Jiangsu Grand Xinyi Pharmaceutical Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Jiangsu Grand Xinyi Pharmaceutical Co., Ltd.; the most recent is dated Sep 12, 2019.
When was Jiangsu Grand Xinyi Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Jiangsu Grand Xinyi Pharmaceutical Co., Ltd. is a Form 483 dated Sep 12, 2019, for the site in Yancheng, China.
What did FDA cite at Jiangsu Grand Xinyi Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Jiangsu Grand Xinyi Pharmaceutical Co., Ltd. are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.