# FDA 483 - High Technology, Inc. - April 08, 2019

Source: https://www.globalkeysolutions.net/records/483/high-technology-inc/d39d4fd5-dd33-4a97-a77e-48342417f1ac

> FDA 483 for High Technology, Inc. on April 08, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: High Technology, Inc.
- Inspection Date: 2019-04-08
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Biol Technology, Inc., a manufacturer of IVD devices in North Attleboro, MA, received a Form FDA 483 with six observations during an inspection. The firm was cited for significant deficiencies across its quality system, including inadequate process validation, corrective and preventive action procedures, and design validation. These issues indicate a lack of robust controls over manufacturing processes, product design, and quality management.

## Related Documents

- [483 - 2019-04-08](https://www.globalkeysolutions.net/records/483/high-technology-inc/e42786b1-c135-41b6-aaea-e3a28907d14c)
- [483 - 2021-08-05](https://www.globalkeysolutions.net/records/483/high-technology-inc/c079635c-35ca-4bbf-8bf6-df6e9cc18652)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

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