Midwest-Tek, Inc. – FDA 483, Apr 1, 2026

An FDA inspection of Midwest-Tek, Inc., a manufacturer in New Albany, IN, revealed significant deficiencies in their quality system. The firm failed to adequately validate production processes, manage design changes, implement production controls, maintain records for nonconforming products, and document record control procedures. These issues indicate a lack of robust quality management practices across several critical areas.