# FDA 483 - Kavis Pharma LLC - April 09, 2025

Source: https://www.keypedia.com/records/483/kavis-pharma-llc/1fd3fa56-811e-45c5-ba1c-9065e86f21dd

> FDA 483 for Kavis Pharma LLC on April 09, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kavis Pharma LLC
- Inspection Date: 2025-04-09
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: 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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Company: https://www.keypedia.com/companies/kavis-pharma-llc/453e3985-3964-40f5-aeaf-89cd2cb6f954

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9