483
Chattem IncChattem Inc – FDA 483, Mar 13, 2020
Record Details
Chattem Plant 1 in Chattanooga, TN, was inspected from March 9-13, 2020, and received one observation related to inadequate maintenance of equipment and utensils. The inspection found multiple instances of leaking equipment and dirty apparatus used in the manufacturing of OTC creams, ointments, lotions, and liquid products. This indicates a failure to prevent malfunctions that could impact drug product safety, identity, strength, quality, or purity.
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ID · 0647991c-0755-48a7-8806-17e1c3e38c5f
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