ScieGen Pharmaceuticals, INC.
Form 483 issued April 21, 2023 · Hauppauge, New York
- Inspection
- Apr 21, 2023
- Investigator
- Xikui Chen
- Observations
- 1
- Pages
- 2
- FEI number
- 3008298016
In short: On April 21, 2023, FDA issued a Form 483 with 1 observation to ScieGen Pharmaceuticals, INC. in Hauppauge, New York (FEI 3008298016) after an inspection that ran Apr 21, 2023. The investigator was Xikui Chen.
What FDA observed
Preview: the opening words of each observation- 01
The firm did not retain appropriate reserve samples for the reference products utilized for the in…
This inspection in context
Xikui Chen
3 documents · 2010–2023
Cites 320.29 (analytical methods for an in vivo bioavailability or bioequivalence study) more than any other section. Most of their documents are for sites in Texas.
The firmScieGen Pharmaceuticals, INC. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at ScieGen Pharmaceuticals, INC.?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected ScieGen Pharmaceuticals, INC.?
Xikui Chen is named on this Form 483, for the inspection of Apr 21, 2023. Each investigator has a profile showing what they cite most.
When was ScieGen Pharmaceuticals, INC. inspected by FDA?
The inspection ran Apr 21, 2023, and the Form 483 is dated April 21, 2023.
How do I get the full Form 483 for ScieGen Pharmaceuticals, INC.?
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.