FDA 483 - Wells Pharma of Houston LLC - December 14, 2022

An FDA inspection of Wells Pharma of Houston LLC, an outsourcing facility, revealed significant deficiencies in their quality control unit, equipment validation, and facility design. Observations included inadequate validation of an electronic building monitoring system, a critical gap in a cleanroom pass-through, and insufficient written procedures for environmental monitoring. These issues raise concerns about the firm's ability to assure proper performance and prevent contamination in the production of sterile and non-sterile drug products.