Jiangsu Nhwa Pharmaceutical Co., Ltd.
FDA inspection history in Xuzhou, China, 2019 to 2023
- 2
- Close-outs
- 2
- Form 483s
Every document, by year
- Close-out
- Form 483
2019: one close-out letter and one Form 483; 2023: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One close-out letter and one Form 483, at Xuzhou, China.
- 2019The longest 483 on file: 6 observations over 5 pages at Xuzhou, China.
- 2023One close-out letter and one Form 483, at Xuzhou, China.
Cited most
Across all Jiangsu Nhwa Pharmaceutical Co. observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.115Reprocessing1
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
The complete Jiangsu Nhwa Pharmaceutical 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
Xuzhou, China
Two Form 483s and one close-out letter · 2019 to 2023 · 9 observations
Latest: Form 483, Sep 1, 2023 →
Also: one document not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-11-17 | Close-out Close-out letter | — | — | $99 |
| 2023-09-01 | 483 Form 483 | Xuzhou, China | 3 | $99 |
| 2019-09-10 | Close-out Close-out letter | Xuzhou, China | — | $99 |
| 2019-04-05 | 483 Form 483 | Xuzhou, China | 6 | $99 |
Investigators on these documents
FEI number 3005619485 · most recent document Nov 17, 2023
About Jiangsu Nhwa Pharmaceutical Co., Ltd.
How many FDA Form 483s has Jiangsu Nhwa Pharmaceutical Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Jiangsu Nhwa Pharmaceutical Co., Ltd.; the most recent is dated Sep 1, 2023.
When was Jiangsu Nhwa Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Jiangsu Nhwa Pharmaceutical Co., Ltd. is a Form 483 dated Sep 1, 2023, for the site in Xuzhou, China.
What did FDA cite at Jiangsu Nhwa Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Jiangsu Nhwa Pharmaceutical Co., Ltd. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.115 (Reprocessing), 1 time; 21 CFR 211.160 (General requirements), 1 time.