Hisun Pharmaceutical (Hangzhou) Co., Ltd.
FDA inspection history in Hangzhou, China, 2016 to 2021
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Hangzhou, China.
- 2016The longest 483 on file: 12 observations over 10 pages at Hangzhou, China.
- 2021One Form 483, at Hangzhou, China.
Cited most
Across all Hisun Pharmaceutical (Hangzhou) Co. observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.42Design and construction features2
The complete Hisun Pharmaceutical (Hangzhou) Co. file.
All 2 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
Hangzhou, China
Two Form 483s · 2016 to 2021 · 15 observations
Latest: Form 483, Jul 20, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-07-20 | 483 Form 483 | Hangzhou, China | 3 | $99 |
| 2016-10-27 | 483 Form 483 | Hangzhou, China | 12 | $99 |
Investigators on these documents
FEI number 3008481334 · most recent document Jul 20, 2021
About Hisun Pharmaceutical (Hangzhou) Co., Ltd.
How many FDA Form 483s has Hisun Pharmaceutical (Hangzhou) Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Hisun Pharmaceutical (Hangzhou) Co., Ltd.; the most recent is dated Jul 20, 2021.
When was Hisun Pharmaceutical (Hangzhou) Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Hisun Pharmaceutical (Hangzhou) Co., Ltd. is a Form 483 dated Jul 20, 2021, for the site in Hangzhou, China.
What did FDA cite at Hisun Pharmaceutical (Hangzhou) Co., Ltd.?
The regulations cited most in the observations on file for Hisun Pharmaceutical (Hangzhou) Co., Ltd. are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.160 (General requirements), 2 times.