# FDA 483 - Phamedica Inc. - December 10, 2021

Source: https://www.keypedia.com/records/483/phamedica-inc/dbc20069-ea04-44a9-b84d-fec58d3fe31b

> FDA 483 for Phamedica Inc. on December 10, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Phamedica Inc.
- Inspection Date: 2021-12-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Phamedica Inc. in Plainview, NY, a manufacturer of the PHA S1 Spinal System, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included failures to establish a complete design history file, inadequately document process validation activities, and maintain proper device history records, indicating a lack of control over design and manufacturing processes.

## Related Documents

- [483 - 2020-01-10](https://www.keypedia.com/records/483/phamedica-inc/f4455089-f20f-4f88-9884-d6268c223745)

## Related Officers

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

Company: https://www.keypedia.com/companies/phamedica-inc/48b0ef24-57a6-4166-bd08-46830f1f3d23

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