# FDA 483 - HHS Systems Inc. - April 25, 2019

Source: https://www.globalkeysolutions.net/records/483/hhs-systems-inc/57bc8d3f-b540-469b-831b-85d5efb6c676

> FDA 483 for HHS Systems Inc. on April 25, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HHS Systems Inc.
- Inspection Date: 2019-04-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of MHS Systems Inc. in Suffern, NY, a medical device manufacturer, revealed significant deficiencies across its quality system. The firm failed to maintain product acceptance status, establish numerous critical quality system procedures, and properly define its organizational structure for design controls. These observations indicate a fundamental lack of established controls and procedures essential for ensuring device quality and regulatory compliance.

## Related Officers

- [Andrew J. Garufi](https://www.globalkeysolutions.net/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.globalkeysolutions.net/companies/hhs-systems-inc/9f78510a-2095-44a5-b1ac-0611cd8d32ad

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