Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory
FDA inspection history in Xinchang, China, 2015 to 2025
- 2
- Form 483s
- 2
- Close-outs
Every document, by year
- Form 483
- Close-out
2015: one Form 483; 2016: one close-out letter; 2017: one close-out letter; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17Two close-out letters and one Form 483, at Xinchang, China.
- 2015The longest 483 on file: 8 observations over 6 pages at Xinchang, China.
- 2025One Form 483, at Xinchang, China.
Cited most
Across all Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory observations on file
- 21 CFR 211.160General requirements1
The complete Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory 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
Xinchang, China
Two Form 483s and one close-out letter · 2015 to 2025 · 9 observations
Latest: Form 483, Mar 7, 2025 →
Also: one document not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-07 | 483 Form 483 | Xinchang, China | 1 | $99 |
| 2017-11-09 | Close-out Close-out letter | — | — | $99 |
| 2016-08-04 | Close-out Close-out letter | Xinchang, China | — | $99 |
| 2015-06-18 | 483 Form 483 | Xinchang, China | 8 | $99 |
Investigators on these documents
Age Se Guang Gao (1)Guang Gao (1)Monica E. Murie (1)Victoria Spivak (1)
FEI number 3003631275 · most recent document Mar 7, 2025
About Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory
How many FDA Form 483s has Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory received?
FDA Intel has 2 Form 483s on file for Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory; the most recent is dated Mar 7, 2025.
When was Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory last inspected by FDA?
The most recent FDA inspection document on file for Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory is a Form 483 dated Mar 7, 2025, for the site in Xinchang, China.
What did FDA cite at Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory?
The regulations cited most in the observations on file for Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory are 21 CFR 211.160 (General requirements), 1 time.