Autumn HarpApril 30, 2025

FDA 483 - Autumn Harp - April 30, 2025

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Record Details

An FDA inspection of Autumn Harp, Inc. in Essex Junction, VT, revealed deficient component testing practices. The firm failed to adequately test all containers of Glycerin USP 99.7% for ethylene glycol/diethylene glycol impurities, despite using this component in the manufacture of SPF sunscreen drug products. This indicates a significant lapse in quality control for raw materials.

Company: Autumn Harp
Inspection Date: April 30, 2025
Product Type: Drugs
Office: New England District Office
Person: Armen H. Youssoufian

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ID · ac0d2006-dde8-40a2-ba70-c5fb33083dd4