# FDA 483 - Circulatory Technology Inc. - December 04, 2019

Source: https://www.globalkeysolutions.net/records/483/circulatory-technology-inc/c7332606-366b-4127-93d2-a00dee5daec4

> FDA 483 for Circulatory Technology Inc. on December 04, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Circulatory Technology Inc.
- Inspection Date: 2019-12-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Circulatory Technology Inc. in Oyster Bay, NY, a medical device manufacturer, was inspected by the FDA from November 6 to December 4, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including failures in medical device reporting, design controls, document control, CAPA, purchasing controls, and process validation. These issues indicate a systemic lack of adherence to regulatory requirements for device manufacturing.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/circulatory-technology-inc/255fb45c-cf2e-4267-9a72-23bb35fe3e5e

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