# FDA 483 - Interscope, Inc. - May 05, 2023

Source: https://www.keypedia.com/records/483/interscope-inc/0af378b1-16a4-4d22-a81f-aa4911005dd8

> FDA 483 for Interscope, Inc. on May 05, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Interscope, Inc.
- Inspection Date: 2023-05-05
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Interscope, Inc. in Northbridge, MA, was inspected by the FDA from May 3-5, 2023. The inspection revealed a significant quality system deficiency related to the control of non-conforming medical devices. Specifically, the firm lacked adequate documented procedures for handling products that failed final acceptance testing, raising concerns about product mix-up and proper disposition.

## Related Officers

- [Katarzyna Plona](https://www.keypedia.com/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)

Company: https://www.keypedia.com/companies/interscope-inc/bd9438fe-6dcd-4df7-ae00-4418482fc4c1

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94