Chattem IncAugust 22, 2025

FDA 483 - Chattem Inc - August 22, 2025

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Record Details

An FDA inspection of Chattem Inc. in Chattanooga, TN, revealed significant deficiencies in the firm's quality system and laboratory controls. Observations included a failure to thoroughly investigate out-of-specification events and prolonged open investigations. Additionally, laboratory records were found incomplete regarding reagent identification and documentation of balance zero weights during testing.

Company: Chattem Inc
Inspection Date: August 22, 2025
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West III
People: Thuy Tram L. Nguyen
Michael Araneta (issuing_officer)
Jeffrey T. Prosterman

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ID · 1124d97e-d527-4a8b-800b-aaadf01694c4