# FDA 483 - Stickman Dialysis Industries, LLC - August 08, 2019

Source: https://www.globalkeysolutions.net/records/483/stickman-dialysis-industries-llc/83378a71-75fd-4d83-b8ee-2a831e7ef3b7

> FDA 483 for Stickman Dialysis Industries, LLC on August 08, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stickman Dialysis Industries, LLC
- Inspection Date: 2019-08-08
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Stickman Dialysis Industries, LLC in Arundel, ME, was inspected, revealing significant deficiencies in its quality system. The firm lacked adequate procedures for equipment calibration, device history records, medical device reporting, quality audits, and management reviews. These observations indicate a broad failure to establish and implement essential controls for regulatory compliance and product quality.

## Related Officers

- [Business Owner](https://www.globalkeysolutions.net/people/james-whitney/072bf37e-a5c6-41bb-b0c1-1f944b112b43)

Company: https://www.globalkeysolutions.net/companies/stickman-dialysis-industries-llc/a4329ef5-6613-4630-8cfd-94b5bd006625

Office: https://www.globalkeysolutions.net/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94