483
Chattem IncFDA 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.
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ID · 15050091-b049-4522-8c16-d1d10d68b3d3