FDA 483 - Peripheral Visions, Inc. - August 10, 2018

Peripheral Visions, Inc., a manufacturer of Class II clinical chemistry electrodes, was cited for numerous fundamental quality system deficiencies during an FDA inspection. The firm failed to establish written procedures for critical areas such as Medical Device Reporting, complaint handling, CAPA, quality audits, management review, design control, training, and equipment calibration. This indicates a severe and systemic breakdown in the firm's quality management system.