# FDA 483 - Parks Medical Electronics, Inc - June 15, 2023

Source: https://www.keypedia.com/records/483/parks-medical-electronics-inc/f653a6eb-ec13-4579-b3b3-93ac8bafe942

> FDA 483 for Parks Medical Electronics, Inc on June 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Parks Medical Electronics, Inc
- Inspection Date: 2023-06-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Parks Medical Electronics, Inc. in Aloha, OR, was inspected regarding its manufacturing of Class 2 medical devices, specifically ultrasound probes. The inspection revealed significant deficiencies in process validation, equipment calibration and maintenance, and corrective and preventive action procedures. These issues indicate a lack of adherence to established quality system requirements.

## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.keypedia.com/companies/parks-medical-electronics-inc/240f7c8a-ba3d-4b5d-847f-1d884c9eea15

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822