Jiangsu Nhwa Pharmaceutical Co., Ltd.
Form 483 issued September 1, 2023 · Xuzhou, China
- Inspection
- Aug 28 – Sep 1, 2023
- Investigator
- Ers Alan P. Kurtaberg
- Observations
- 3
- Pages
- 3
- FEI number
- 3005619485
In short: On September 1, 2023, FDA issued a Form 483 with 3 observations to Jiangsu Nhwa Pharmaceutical Co., Ltd. in Xuzhou, Jiangsu (FEI 3005619485) after an inspection that ran Aug 28 – Sep 1, 2023. The investigator was Ers Alan P. Kurtaberg. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaint investigation is…
- 02
Written procedure is not followed to…
- 03
Raw materials and APIs are not always…
This inspection in context
Ers Alan P. Kurtaberg
1 document · 2023
Cites 211.198 (complaint files) more than any other section. Most of their documents are for sites in China.
The firmJiangsu Nhwa Pharmaceutical Co., Ltd. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jiangsu Nhwa Pharmaceutical Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about quality system and materials. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Jiangsu Nhwa Pharmaceutical Co., Ltd.?
Ers Alan P. Kurtaberg is named on this Form 483, for the inspection of Aug 28 – Sep 1, 2023. Each investigator has a profile showing what they cite most.
When was Jiangsu Nhwa Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Aug 28 – Sep 1, 2023, and the Form 483 is dated September 1, 2023.
How do I get the full Form 483 for Jiangsu Nhwa Pharmaceutical Co., Ltd.?
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