FDA 483 - Prizm Medical, Inc. - October 25, 2021

An FDA inspection of Prizm Medical, Inc., a medical device manufacturer in Buford, GA, was conducted from October 18 to October 25, 2021. The inspection identified two primary observations concerning the company's quality system.

The first observation highlighted inadequate documentation of acceptance activities. Specifically, results from receiving inspections for products like Electro Mesh Gloves, Sleeves, and Silver Thera Stockings were not recorded. Additionally, in-process acceptance test results for circuit boards and the outcomes of testing performed during complaint investigations for returned devices (including oscilloscope and battery tests for various models) lacked proper documentation.

The second observation noted that procedures for controlling nonconforming products were not adequately established or implemented. The firm's Nonconformance Procedure was not followed, as evidenced by the absence of nonconformance forms for circuit boards that failed in-process testing. Furthermore, several customer complaints detailing product malfunctions, such as power issues, vibrations, and structural defects in MZM 100 devices, were not documented with the required nonconformance forms.

These findings suggest a need for Prizm Medical, Inc. to implement robust corrective actions to ensure compliance with quality system requirements under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, particularly regarding documentation and nonconformance control.