Hangzhou Huadong Medicine Group Kangrun Pharmaceutical
Form 483 issued January 22, 2015 · Xiaofeng Town, Anji, China
- Inspection
- Jan 19 – Jan 22, 2015
- Investigator
- Jeffrey D. Meng
- Observations
- 7
- Pages
- 2
- FEI number
- 3008465758
In short: On January 22, 2015, FDA issued a Form 483 with 7 observations to Hangzhou Huadong Medicine Group Kangrun Pharmaceutical in Xiaofeng Town, Anji, Zhejiang (FEI 3008465758) after an inspection that ran Jan 19 – Jan 22, 2015. The investigator was Jeffrey D. Meng. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.68 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Adequate process performance qualification of critical process steps for^<4> API was not performed although all finished…
- 03
An out-of-trend investigation was not initiated relating…
- 04
The documentation and evaluation of equipment calibration and…
This inspection in context
Jeffrey D. Meng
14 documents · 2010–2016
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Michigan.
The firmHangzhou Huadong Medicine Group Kangrun Pharmaceutical history
The site's inspection history, in date order.
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 Hangzhou Huadong Medicine Group Kangrun Pharmaceutical?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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 Hangzhou Huadong Medicine Group Kangrun Pharmaceutical?
Jeffrey D. Meng is named on this Form 483, for the inspection of Jan 19 – Jan 22, 2015. Each investigator has a profile showing what they cite most.
When was Hangzhou Huadong Medicine Group Kangrun Pharmaceutical inspected by FDA?
The inspection ran Jan 19 – Jan 22, 2015, and the Form 483 is dated January 22, 2015.
How do I get the full Form 483 for Hangzhou Huadong Medicine Group Kangrun Pharmaceutical?
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