# FDA 483 - Triumvirate Environmental, Inc. - March 18, 2019

Source: https://www.globalkeysolutions.net/records/483/triumvirate-environmental-inc/6f92890c-887f-4375-8d07-b4e539d0fba8

> FDA 483 for Triumvirate Environmental, Inc. on March 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Triumvirate Environmental, Inc.
- Inspection Date: 2019-03-18
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Triumvirate Environmental, Inc. in Somerville, MA, a medical device manufacturer, revealed significant quality system deficiencies. Observations included a lack of documented personnel training, absence of written Medical Device Reporting (MDR) procedures, inadequate control of non-conforming products, and failure to include Unique Device Identifiers (UDI) in device history records or the GUDID database. These issues indicate a need for improved quality management practices at the facility.

## Related Officers

- [Nabil Nakhoul](https://www.globalkeysolutions.net/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.globalkeysolutions.net/companies/triumvirate-environmental-inc/d2ca4e5d-32bd-4edf-a32d-8c85a71eee4e

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