Sciegen Pharmaceuticals IncApril 17, 2023

FDA 483 - Sciegen Pharmaceuticals Inc - April 17, 2023

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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)

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