Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Form 483 issued May 13, 2016 · Ezhou, China
- Inspection
- May 9 – May 13, 2016
- Investigator
- Alice S. Loo
- Observations
- 2
- Pages
- 1
- FEI number
- 3004117486
In short: On May 13, 2016, FDA issued a Form 483 with 2 observations to Hubei Gedian Humanwell Pharmaceutical Co., Ltd. in Ezhou, China (FEI 3004117486) after an inspection that ran May 9 – May 13, 2016. The investigator was Alice S. Loo. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to adequaiely calibrate the fovated at according…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Alice S. Loo
1 document · 2016
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in China.
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 211.68
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 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Hubei Gedian Humanwell Pharmaceutical Co., Ltd.?
Alice S. Loo is named on this Form 483, for the inspection of May 9 – May 13, 2016. Each investigator has a profile showing what they cite most.
When was Hubei Gedian Humanwell Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran May 9 – May 13, 2016, and the Form 483 is dated May 13, 2016.
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.