Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
FDA inspection history in Ezhou, China, 2013 to 2026
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2013: one Form 483; 2016: one Form 483; 2019: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One Form 483, at Ezhou, China.
- 2016One Form 483, at Ezhou, China.
- 2016The longest 483 on file: 2 observations over 1 pages at Ezhou, China.
- 2019One Form 483, at Ezhou, China.
- 2026One warning letter.
Cited most
Across all Hubei Gedian Humanwell Pharmaceutical Co. observations on file
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Hubei Gedian Humanwell 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
Ezhou, China
Three Form 483s · 2013 to 2019 · 4 observations
Latest: Form 483, Jun 28, 2019 →
Also: one document not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-06-03 | Warning letter Warning letter | — | — | $99 |
| 2019-06-28 | 483 Form 483 | Ezhou, China | 1 | $99 |
| 2016-05-13 | 483 Form 483 | Ezhou, China | 2 | $99 |
| 2013-10-17 | 483 Form 483 | Ezhou, China | 1 | $99 |
Investigators on these documents
Alice S. Loo (1)Jose E. Melendez (1)Uttaniti Limchumroon (1)
FEI number 3004117486 · most recent document Jun 3, 2026
About Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
How many FDA Form 483s has Hubei Gedian Humanwell Pharmaceutical Co., Ltd. received?
FDA Intel has 3 Form 483s on file for Hubei Gedian Humanwell Pharmaceutical Co., Ltd.; the most recent is dated Jun 28, 2019.
When was Hubei Gedian Humanwell Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Hubei Gedian Humanwell Pharmaceutical Co., Ltd. is a Form 483 dated Jun 28, 2019, for the site in Ezhou, China.
What did FDA cite at Hubei Gedian Humanwell Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Hubei Gedian Humanwell Pharmaceutical Co., Ltd. are 21 CFR 211.142 (Warehousing procedures), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 1 time.
Has Hubei Gedian Humanwell Pharmaceutical Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hubei Gedian Humanwell Pharmaceutical Co., Ltd.; the most recent is dated Jun 3, 2026.