# FDA 483 - US Merchandise LLC - June 28, 2023

Source: https://www.keypedia.com/records/483/us-merchandise-llc/e1ba34c8-4ea0-476a-b6b2-7dd17dfb3bd1

> FDA 483 for US Merchandise LLC on June 28, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: US Merchandise LLC
- Inspection Date: 2023-06-28
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of US Merchandise LLC, an initial importer in Westbury, NY, revealed two significant observations related to the lack of established written procedures. The firm failed to develop written Medical Device Report (MDR) procedures and also lacked procedures for receiving, reviewing, and evaluating customer complaints. These findings indicate a fundamental deficiency in the firm's quality system regarding post-market surveillance and complaint handling.

## Related Officers

- [Preston M. Lee](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/us-merchandise-llc/4cae8770-a1d4-48c0-85e4-efedfa6caf84

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961