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483
•Sciegen Pharmaceuticals Inc•April 17, 2023

Sciegen Pharmaceuticals Inc – FDA 483, Apr 17, 2023

Record Details

An FDA inspection of ScieGen Pharmaceuticals Inc., an analytical laboratory in Hauppauge, NY, identified one observation. The firm was cited for failing to retain appropriate reserve samples for reference products used in an in vitro comparative dissolution study. This indicates a deficiency in their sample retention practices.

Company
Sciegen Pharmaceuticals Inc
Inspection date
April 17, 2023
Product type
drugs
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person
  • Xikui Chen (Pharmacologist at FDA)
View Company Profile

ID · e2f9042a-4ff1-46f0-bbb2-f2cb753419c1

Other documents for Sciegen Pharmaceuticals Inc
  • 483 - 2022-09-02September 2, 2022
  • 483 - 2021-12-20December 20, 2021
  • EIR - 2019-06-21June 21, 2019
  • EIR - 2018-03-16March 16, 2018
  • 483 - 2015-01-09January 9, 2015

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