# FDA 483 - Equashield LLC - December 08, 2021

Source: https://www.keypedia.com/records/483/equashield-llc/d6bc99bc-a8d5-45e7-b347-b887bfff3e83

> FDA 483 for Equashield LLC on December 08, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Equashield LLC
- Inspection Date: 2021-12-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Equashield LLC, a medical device importer in Port Washington, NY, was inspected by the FDA, revealing a significant compliance issue. The firm failed to maintain written Medical Device Reporting (MDR) procedures. Specifically, it lacked electronic MDR procedures and an Electronic Submissions Gateway (ESG) account for handling serious injury and death incidents.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/equashield-llc/92376d5a-8804-4d15-ac23-d4131218bb5f

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