# FDA 483 - Tecomet Inc. - January 09, 2020

Source: https://www.globalkeysolutions.net/records/483/tecomet-inc/70777330-a1ce-4863-a428-1fcde07968c1

> FDA 483 for Tecomet Inc. on January 09, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tecomet Inc.
- Inspection Date: 2020-01-09
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Tecomet Inc., a medical device manufacturer in Wilmington, MA, revealed significant deficiencies in their quality system. The firm lacked adequate procedures for controlling purchased products and services, failed to document finished device acceptance, and did not maintain proper personnel training records. These issues indicate a need for improved adherence to quality system regulations, particularly concerning supplier management, product release, and employee competency.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/allison-a-rodriguez/4298721f-e09d-4881-8e90-3277ceb17e7d)
- [Sara M. Onyango](https://www.globalkeysolutions.net/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.globalkeysolutions.net/companies/tecomet-inc/1135970d-7a63-4e05-9b75-157100285ac4

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