FDA 483 - The Snore Reliever Company LLC - February 05, 2020

The FDA inspected The Snore Reliever Company LLC in North Bergen, NJ, a repacker and own-label distributor of anti-snoring mouthpieces. The inspection revealed significant deficiencies in the firm's quality system, including a complete lack of established procedures for critical operations, failure to investigate thousands of device complaints, and inadequate control over nonconforming products. These issues indicate a fundamental absence of quality management practices.