# FDA 483 - SM Worldwide USA, Inc. - February 05, 2020

Source: https://www.globalkeysolutions.net/records/483/sm-worldwide-usa-inc/6eb0f88b-dfbf-4444-a7b4-296ca70868d5

> FDA 483 for SM Worldwide USA, Inc. on February 05, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SM Worldwide USA, Inc.
- Inspection Date: 2020-02-05
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of GM Worldwide USA, Inc., a medical device importer in Jamaica, NY, revealed significant deficiencies in their quality system. The firm was cited for failing to establish written procedures for Medical Device Reporting (MDR), complaint handling, and corrective and preventive actions (CAPA). These observations indicate a fundamental lack of critical operational controls.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/sm-worldwide-usa-inc/b6d4ec5a-fe23-426d-b87a-70ab44220e46

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