Fieldtex Products, Inc. – FDA 483, Oct 4, 2022

Fieldtex Products, Inc., a medical device manufacturer in Rochester, NY, was cited with eight observations during an FDA inspection from September 30 to October 4, 2022. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for supplier control, nonconforming product, CAPA, process control, complaint handling, and a lack of essential documentation. These issues indicate a broad failure to establish and maintain a compliant quality system for medical device manufacturing.