Zhejiang Hisun Pharmaceutical Co., Ltd.
FDA inspection history across 2 sites, 2015 to 2019
- 3
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2015: one warning letter; 2017: two Form 483s and one close-out letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Three Form 483s, one warning letter and one close-out letter, at Taizhou, China and Taizhou City, China.
- 2017The longest 483 on file: 2 observations over 3 pages at Taizhou City, China.
Cited most
Across all Zhejiang Hisun Pharmaceutical Co. observations on file
- 21 CFR 211.194Laboratory records4
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.166Stability testing2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
The complete Zhejiang Hisun Pharmaceutical Co. file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Taizhou, China
Two Form 483s · 2017 to 2019
Latest: Form 483, Jun 7, 2019 →Taizhou City, China
One Form 483 · 2017 · 2 observations
Latest: Form 483, Jan 19, 2017 →
Also: two documents not tied to a site.
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-07 | 483 Form 483 | Taizhou, China | — | $99 |
| 2017-08-11 | 483 Form 483 | Taizhou, China | — | $99 |
| 2017-06-01 | Close-out Close-out letter | — | — | $99 |
| 2017-01-19 | 483 Form 483 | Taizhou City, China | 2 | $99 |
| 2015-12-31 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
FEI number 3007719313 · most recent document Jun 7, 2019
About Zhejiang Hisun Pharmaceutical Co., Ltd.
How many FDA Form 483s has Zhejiang Hisun Pharmaceutical Co., Ltd. received?
FDA Intel has 3 Form 483s on file for Zhejiang Hisun Pharmaceutical Co., Ltd.; the most recent is dated Jun 7, 2019.
When was Zhejiang Hisun Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Zhejiang Hisun Pharmaceutical Co., Ltd. is a Form 483 dated Jun 7, 2019, for the site in Taizhou, China.
What did FDA cite at Zhejiang Hisun Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Zhejiang Hisun Pharmaceutical Co., Ltd. are 21 CFR 211.194 (Laboratory records), 4 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.166 (Stability testing), 2 times.
Has Zhejiang Hisun Pharmaceutical Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Zhejiang Hisun Pharmaceutical Co., Ltd.; the most recent is dated Dec 31, 2015.