Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.
Form 483 issued July 26, 2018 · Changzhou, China
- Inspection
- Jul 23 – Jul 26, 2018
- Investigator
- Truong X. Nguyen
- Observations
- 2
- Pages
- 1
- FEI number
- 3001599766
In short: On July 26, 2018, FDA issued a Form 483 with 2 observations to Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. in Changzhou, Jiangsu (FEI 3001599766) after an inspection that ran Jul 23 – Jul 26, 2018. The investigator was Truong X. Nguyen. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Observations span 1 system, led by laboratory controls.
Most cited: 21 CFR 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
Control records are not…
- 02
QA does not perform comprehensive reviews…
This inspection in context
Truong X. Nguyen
20 documents · 2011–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmJiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.?
Truong X. Nguyen is named on this Form 483, for the inspection of Jul 23 – Jul 26, 2018. Each investigator has a profile showing what they cite most.
When was Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. inspected by FDA?
The inspection ran Jul 23 – Jul 26, 2018, and the Form 483 is dated July 26, 2018.
How do I get the full Form 483 for Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.?
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