# FDA 483 - Pinnacle Biologics Inc - June 27, 2022

Source: https://www.keypedia.com/records/483/pinnacle-biologics-inc/e6d5679e-d683-4a33-b634-2ddc38c379cf

> FDA 483 for Pinnacle Biologics Inc on June 27, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pinnacle Biologics Inc
- Inspection Date: 2022-06-27
- Product Type: device
- Office Name: Chicago District Office
- Summary: Pinnacle Biologics Inc, a specification developer in Bannockburn, IL, received a Form 483 for deficiencies in its medical device reporting and complaint handling procedures. The firm failed to submit Medical Device Reports (MDRs) within the required 30-day timeframe and did not adequately evaluate or investigate complaints, particularly those related to its Photodynamic Therapy (PDT) combination product. These issues indicate a lack of robust quality system controls for post-market surveillance.

## Related Documents

- [483 - 2025-06-13](https://www.keypedia.com/records/483/pinnacle-biologics-inc/1b5664cf-7c80-4d1f-9a6b-ea2dbdd91c53)

## Related Officers

- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

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