# FDA 483 - Pinnacle Biologics Inc - June 13, 2025

Source: https://www.keypedia.com/records/483/pinnacle-biologics-inc/1b5664cf-7c80-4d1f-9a6b-ea2dbdd91c53

> FDA 483 for Pinnacle Biologics Inc on June 13, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pinnacle Biologics Inc
- Inspection Date: 2025-06-13
- Product Type: device
- Office Name: Chicago District Office
- Summary: Pinnacle Biologics Inc, located in Bannockburn, IL, was inspected from June 10-13, 2025. The inspection revealed a significant issue with the firm's failure to submit Medical Device Reports (MDRs) within 30 days for device malfunctions, specifically broken fibers during Photodynamic Therapy (PDT) procedures. This indicates a serious lapse in reporting potentially harmful device issues that could cause or contribute to a death or serious injury if recurrent.

## Related Documents

- [483 - 2022-06-27](https://www.keypedia.com/records/483/pinnacle-biologics-inc/e6d5679e-d683-4a33-b634-2ddc38c379cf)

## Related Officers

- [Natasha R. Johnson](https://www.keypedia.com/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

Company: https://www.keypedia.com/companies/pinnacle-biologics-inc/c497d9fb-e403-4095-8c90-3607e789a5f1

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669