FDA 483 - Meditherm Inc. - September 02, 2022

An FDA inspection of Meditherm Inc., a medical device manufacturer in Albuquerque, NM, revealed significant deficiencies in their quality system. The firm failed to establish procedures for design changes, incoming product acceptance, and supplier requirements. Additionally, no quality audits or management review meetings had been conducted in the past three years, indicating a severely lacking quality management system.