# FDA 483 - Health Care Technology - April 25, 2022

Source: https://www.keypedia.com/records/483/health-care-technology/3e758059-455a-4051-a31d-ba71fb9cc376

> FDA 483 for Health Care Technology on April 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Health Care Technology
- Inspection Date: 2022-04-25
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Health Care Technology in Ashland, MA, revealed significant deficiencies across its quality system. The firm failed to establish and maintain adequate procedures for design control, purchasing, storage, device distribution, quality audits, management review, and employee training. These widespread issues indicate a fundamental lack of control over critical manufacturing processes for their medical devices.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/health-care-technology/7df15e54-09c8-4910-9afa-7bea94f816d2

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