Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Form 483 issued October 17, 2013 · Ezhou, China
- Investigator
- Jose E. Melendez
- Observations
- 1
- Pages
- 1
- FEI number
- 3004117486
In short: On October 17, 2013, FDA issued a Form 483 with 1 observation to Hubei Gedian Humanwell Pharmaceutical Co., Ltd. in Ezhou, Hubei (FEI 3004117486). The investigator was Jose E. Melendez. Most observations concern materials; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.142 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your Quality Unit failed to implement adequate controls for preventing adverse effects to API drug products…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.142
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 materials. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected Hubei Gedian Humanwell Pharmaceutical Co., Ltd.?
Jose E. Melendez is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Hubei Gedian Humanwell Pharmaceutical Co., Ltd. inspected by FDA?
This Form 483 is dated October 17, 2013.
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.