# FDA 483 - High Technology, Inc. - August 05, 2021

Source: https://www.globalkeysolutions.net/records/483/high-technology-inc/c079635c-35ca-4bbf-8bf6-df6e9cc18652

> FDA 483 for High Technology, Inc. on August 05, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: High Technology, Inc.
- Inspection Date: 2021-08-05
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: High Technology, Inc. in North Attleboro, MA, a medical device manufacturer, was cited with two observations during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, specifically regarding supplier corrective actions for low quality cards. Additionally, their calibration procedures lacked provisions for remedial action to assess the impact on device quality when accuracy and precision limits were not met.

## Related Documents

- [483 - 2019-04-08](https://www.globalkeysolutions.net/records/483/high-technology-inc/e42786b1-c135-41b6-aaea-e3a28907d14c)
- [483 - 2019-04-08](https://www.globalkeysolutions.net/records/483/high-technology-inc/d39d4fd5-dd33-4a97-a77e-48342417f1ac)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/high-technology-inc/45972077-9dc7-4327-88d6-79e70b7d913c

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7