FDA 483 - Inman Orthodontic Laboratories, Inc. - December 18, 2024

Inman Orthodontic Laboratories, Inc. in Coral Springs, FL, was cited for ten significant quality system deficiencies during an FDA inspection. The firm failed to establish and implement fundamental procedures for quality audits, training, CAPA, design control, device master records, complaint handling, nonconforming product, supplier management, management review, and document approval. These widespread issues indicate a severe lack of adherence to regulatory requirements for medical device manufacturing.