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483
•GFS Chemicals Inc•November 17, 2023

GFS Chemicals Inc – FDA 483, Nov 17, 2023

Record Details

GFS Chemicals Inc in Columbus, OH was inspected by the FDA from November 14-17, 2023. The inspection revealed a significant deficiency in process validation, specifically the lack of adequately established procedures for monitoring and controlling process parameters. This included a failure to complete performance qualification (PQ) after equipment changes and the absence of an updated process validation procedure.

Company
GFS Chemicals Inc
Inspection date
November 17, 2023
Product type
drugs
Office
Cincinnati District Office
Person
  • Javonica F. Penn (investigator)
View Company Profile

ID · 023fdf62-3e95-41aa-9028-83aa1162e58e

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