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

Source: https://www.keypedia.com/records/483/the-snore-reliever-company-llc/e95658f4-c1c8-4b51-b78f-aa475c94d33c

> FDA 483 for The Snore Reliever Company LLC on February 05, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: The Snore Reliever Company LLC
- Inspection Date: 2020-02-05
- Product Type: device
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [David H. Smith](https://www.keypedia.com/people/david-h-smith/a78c3b20-1fb4-438f-904b-a6ab51a81945)

Company: https://www.keypedia.com/companies/the-snore-reliever-company-llc/59e4c18d-c6f5-4c4f-b387-3fe95907cc04

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248