FDA 483 - Wellbeing Medical Supply - April 25, 2025

Wellbeing Medical Supply, a drug repacking facility in Costa Mesa, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to establish or follow procedures for complaint handling, maintain readily available production and distribution records, provide employee training records, and implement procedures to prevent labeling and packaging mix-ups for its drug products. These issues indicate a lack of fundamental controls over critical operations.