Jiangsu Nhwa Pharmaceutical Co., Ltd.
Form 483 issued April 5, 2019 · Xuzhou, China
- Inspection
- Apr 5, 2019
- Investigator
- Christopher Keating
- Observations
- 6
- Pages
- 5
- FEI number
- 3005619485
In short: On April 5, 2019, FDA issued a Form 483 with 6 observations to Jiangsu Nhwa Pharmaceutical Co., Ltd. in Xuzhou, Jiangsu (FEI 3005619485) after an inspection that ran Apr 5, 2019. The investigator was Christopher Keating. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Test procedures used for analysis and release of stability samples are not scientifically sound and suitable…
- 02
Investigations into product failures and product…
- 03
Laboratory investigation procedures are…
- 04
Your system for reprocessing of APIs which do not meet final QC specification…
This inspection in context
Christopher Keating
13 documents · 2018–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.192
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 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Jiangsu Nhwa Pharmaceutical Co., Ltd.?
Christopher Keating is named on this Form 483, for the inspection of Apr 5, 2019. Each investigator has a profile showing what they cite most.
When was Jiangsu Nhwa Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Apr 5, 2019, and the Form 483 is dated April 5, 2019.
How do I get the full Form 483 for Jiangsu Nhwa 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.