PhytogenX, Inc.March 27, 2025

FDA 483 - PhytogenX, Inc. - March 27, 2025

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Phytogenx, Inc. in Morgantown, PA, was inspected and received a Form 483 with two observations related to quality control. The inspection revealed deficiencies in component testing, specifically for glycerin, and inadequate finished product microbial testing for non-sterile aqueous drug products. These issues indicate potential risks to product quality and patient safety.

Company: PhytogenX, Inc.
Inspection Date: March 27, 2025
Product Type: Drugs
Office: Philadelphia District Office
Person: Stephenie M. Ortiz

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ID · 51916b2b-ebbf-42c3-8bc4-7b9e5cda1f1c