FDA 483 - UFP Technologies, Inc. - August 17, 2022

UFF Technologies, Inc. in Chicopee, MA, a contract manufacturer of Class II medical devices, was inspected by the FDA from August 4-17, 2022. The inspection revealed significant issues related to environmental controls in cleanrooms, inadequate documentation of process validation activities, and deficiencies in maintaining customer complaint files. These findings indicate a need for improved quality system procedures to prevent contamination and ensure product quality.