# FDA 483 - Cerapedics, Inc. - October 24, 2019

Source: https://www.globalkeysolutions.net/records/483/cerapedics-inc/3a5bc35c-a260-468c-b5da-ba534ee10fe5

> FDA 483 for Cerapedics, Inc. on October 24, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cerapedics, Inc.
- Inspection Date: 2019-10-24
- Product Type: device
- Office Name: Denver District Office
- Summary: Cerapedics, Inc. in Westminster, CO, was inspected by the FDA from October 22-24, 2019. The inspection revealed a significant deficiency in their medical device reporting (MDR) process. Specifically, the firm failed to submit an MDR report within 30 days for a serious injury involving their iFactor bone graft putty, despite internal recognition of its reportability.

## Related Documents

- [483 - 2024-03-13](https://www.globalkeysolutions.net/records/483/cerapedics-inc/9aff3ba5-c119-40d7-a208-4ed5530c0a00)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/vicky-l-cruz/282da571-56be-48f4-96c6-d590829b12c2)
- [Tuan A Nguyen](https://www.globalkeysolutions.net/people/tuan-a-nguyen/50723bbb-29a1-4e7a-a5aa-123ec3866065)

Company: https://www.globalkeysolutions.net/companies/cerapedics-inc/f8796d53-5af2-45b4-9f6d-fb2bac4aeea1

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face