Wuxi Fortune Pharmaceutical Co., Ltd.
Form 483 issued September 13, 2023 · Wuxi, China
- Inspection
- Sep 5 – Sep 13, 2023
- Investigator
- Niketa Patel
- Observations
- 3
- Pages
- 3
- FEI number
- 3005968356
In short: On September 13, 2023, FDA issued a Form 483 with 3 observations to Wuxi Fortune Pharmaceutical Co., Ltd. in Wuxi, Jiangsu (FEI 3005968356) after an inspection that ran Sep 5 – Sep 13, 2023. The investigator was Niketa Patel. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
Facilities & equipment and production account for 2 of 3 observations.
Most cited: 21 CFR 211.63 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is…
- 02
Deviation from written production and process control procedures are not recorded and justified…
- 03
to reduce [///™@concentration…
This inspection in context
Niketa Patel
15 documents · 2016–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmWuxi Fortune Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wuxi Fortune Pharmaceutical Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Wuxi Fortune Pharmaceutical Co., Ltd.?
Niketa Patel is named on this Form 483, for the inspection of Sep 5 – Sep 13, 2023. Each investigator has a profile showing what they cite most.
When was Wuxi Fortune Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Sep 5 – Sep 13, 2023, and the Form 483 is dated September 13, 2023.
How do I get the full Form 483 for Wuxi Fortune Pharmaceutical Co., Ltd.?
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