483
Kavis Pharma LLCKavis Pharma LLC – FDA 483, Apr 9, 2025
Record Details
An FDA inspection of Kavis Pharma LLC in Sugar Land, TX, a manufacturer of non-sterile drug products, revealed significant deficiencies. Observations included inadequate procedures for preventing objectionable microorganisms in drug products, failure to ensure backup data integrity for the automated water system, and a lack of systems to comply with DSCSA verification requirements.
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ID · 1fd3fa56-811e-45c5-ba1c-9065e86f21dd
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