Yichang Humanwell Oral Solid Dosage Plant
Form 483 issued June 28, 2019 · Yichang, China
- Inspection
- Jun 24 – Jun 28, 2019
- Investigator
- Marcus A. Ray
- Observations
- 1
- Pages
- 2
- FEI number
- 3008984460
In short: On June 28, 2019, FDA issued a Form 483 with 1 observation to Yichang Humanwell Oral Solid Dosage Plant in Yichang, Hubei (FEI 3008984460) after an inspection that ran Jun 24 – Jun 28, 2019. The investigator was Marcus A. Ray. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern 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
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Marcus A. Ray
14 documents · 2017–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmYichang Humanwell Oral Solid Dosage Plant history
All 2 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 Yichang Humanwell Oral Solid Dosage Plant?
FDA listed 1 observation 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 Yichang Humanwell Oral Solid Dosage Plant?
Marcus A. Ray 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 Yichang Humanwell Oral Solid Dosage Plant 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 Yichang Humanwell Oral Solid Dosage Plant?
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