Yichang Sanxia Pharmaceutical Co., Ltd.
Form 483 issued July 15, 2016 · Yichang, China
- Inspection
- Jul 11 – Jul 15, 2016
- Investigator
- Eviko V. Butler
- Observations
- 2
- Pages
- 1
- FEI number
- 3003274512
In short: On July 15, 2016, FDA issued a Form 483 with 2 observations to Yichang Sanxia Pharmaceutical Co., Ltd. in Yichang, Hubei (FEI 3003274512) after an inspection that ran Jul 11 – Jul 15, 2016. The investigator was Eviko V. Butler. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.166 (1×) · 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There was no assessment from Quality Assurance to evaluate the stability of with the change in…
- 02
Good Documentation practices are…
This inspection in context
Eviko V. Butler
1 document · 2016
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in China.
The firmYichang Sanxia Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Yichang Sanxia Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Yichang Sanxia Pharmaceutical Co., Ltd.?
Eviko V. Butler is named on this Form 483, for the inspection of Jul 11 – Jul 15, 2016. Each investigator has a profile showing what they cite most.
When was Yichang Sanxia Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jul 11 – Jul 15, 2016, and the Form 483 is dated July 15, 2016.
How do I get the full Form 483 for Yichang Sanxia 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.