# FDA 483 - Douglas Terp - June 28, 2021

Source: https://www.globalkeysolutions.net/records/483/douglas-terp/73a8e16a-2387-4fa7-a964-c1027924b3e1

> FDA 483 for Douglas Terp on June 28, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Douglas Terp
- Inspection Date: 2021-06-28
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Douglas Terp, acting as a sponsor-investigator for Colby College, was cited for significant deficiencies in a COVID-19 screening program using an unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test. Observations included using an unconfirmed diagnostic device, initiating an investigation without IRB approval, failing to obtain legally effective informed consent, and not labeling investigational devices correctly. These issues indicate a serious lack of regulatory compliance in human subject protection and device use.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.globalkeysolutions.net/companies/douglas-terp/9a8a18dc-f000-4ad5-9575-d9c8a3460ead

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