FDA 483 - Kavis Pharma LLC - April 09, 2025

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.