# FDA 483 - SurgiMark, Inc. - August 08, 2017

Source: https://www.globalkeysolutions.net/records/483/surgimark-inc/19ff51f2-d68e-4f4a-9b03-7a43c339549d

> FDA 483 for SurgiMark, Inc. on August 08, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SurgiMark, Inc.
- Inspection Date: 2017-08-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of SurgiMark, Inc. in Yakima, WA, conducted on August 7-8, 2017, identified two significant quality system deficiencies. The firm failed to establish adequate procedures for receiving and evaluating complaints, specifically regarding Medical Device Report (MDR) reportability. Additionally, the inspection found that the firm's sampling plans for product inspection were not based on valid statistical rationale.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/surgimark-inc/2ddd33d7-2d24-46ae-8d24-094fdcd20020

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