Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Form 483 issued June 28, 2019 · Ezhou, China
- Inspection
- Jun 24 – Jun 28, 2019
- Investigator
- Uttaniti Limchumroon
- Observations
- 1
- Pages
- 1
- FEI number
- 3004117486
In short: On June 28, 2019, FDA issued a Form 483 with 1 observation to Hubei Gedian Humanwell Pharmaceutical Co., Ltd. in Ezhou, Hubei (FEI 3004117486) after an inspection that ran Jun 24 – Jun 28, 2019. The investigator was Uttaniti Limchumroon. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The preventive maintenance of…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmHubei Gedian Humanwell Pharmaceutical Co., Ltd. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hubei Gedian Humanwell Pharmaceutical Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Hubei Gedian Humanwell Pharmaceutical Co., Ltd.?
Uttaniti Limchumroon is named on this Form 483, for the inspection of Jun 24 – Jun 28, 2019. Each investigator has a profile showing what they cite most.
When was Hubei Gedian Humanwell Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jun 24 – Jun 28, 2019, and the Form 483 is dated June 28, 2019.
How do I get the full Form 483 for Hubei Gedian Humanwell Pharmaceutical Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.