FDA 483 - Amperor Inc. - October 29, 2019

Promisector Inc., an initial importer in Houston, TX, was cited with five observations during an FDA inspection from October 22-29, 2019. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning complaint handling, medical device reporting, control of nonconforming product, corrective and preventive actions, and finished device distribution. These issues indicate a lack of established and implemented procedures for critical quality processes.