FDA 483 - Applied Consumer Services Inc. - September 29, 2025

An FDA inspection of Applied Consumer Services Inc. in Hialeah Gardens, FL, a control laboratory, revealed significant deficiencies in laboratory controls and operations. Observations included inadequate designated areas for microbiological assays, incomplete laboratory records lacking sample dates, and a failure to maintain cleaning and maintenance schedules for critical equipment like laminar flow hoods. These issues indicate a lack of proper controls to prevent contamination and ensure data integrity.