Zhejiang Hisun Pharmaceutical Co., Ltd.
Form 483 issued January 19, 2017 · Taizhou City, China
- Inspection
- Jan 16 – Jan 19, 2017
- Investigators
- Lindsay M. Schweigohann· Peter E. Baker
- Observations
- 2
- Pages
- 3
- FEI number
- 3007719313
In short: On January 19, 2017, FDA issued a Form 483 with 2 observations to Zhejiang Hisun Pharmaceutical Co., Ltd. in Taizhou City, Zhejiang (FEI 3007719313) after an inspection that ran Jan 16 – Jan 19, 2017. The investigators were Lindsay M. Schweigohann and Peter E. Baker. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Quality Control laboratory control procedures…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Lindsay M. Schweigohann
1 document · 2017
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmZhejiang Hisun Pharmaceutical Co., Ltd. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Hisun Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Zhejiang Hisun Pharmaceutical Co., Ltd.?
Lindsay M. Schweigohann and Peter E. Baker are named on this Form 483, for the inspection of Jan 16 – Jan 19, 2017. Each investigator has a profile showing what they cite most.
When was Zhejiang Hisun Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jan 16 – Jan 19, 2017, and the Form 483 is dated January 19, 2017.
How do I get the full Form 483 for Zhejiang Hisun Pharmaceutical Co., Ltd.?
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