# FDA 483 - Cerapedics, Inc. - March 13, 2024

Source: https://www.globalkeysolutions.net/records/483/cerapedics-inc/9aff3ba5-c119-40d7-a208-4ed5530c0a00

> FDA 483 for Cerapedics, Inc. on March 13, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cerapedics, Inc.
- Inspection Date: 2024-03-13
- Product Type: device
- Office Name: Denver District Office
- Summary: Cerapedics, Inc., a medical device manufacturer in Westminster, CO, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to timely report numerous serious adverse events for its i-FACTOR Putty, indicating systemic issues with its Medical Device Reporting, complaint handling, corrective and preventive action, and personnel training procedures. This includes a repeat observation regarding MDR reporting failures.

## Related Documents

- [483 - 2019-10-24](https://www.globalkeysolutions.net/records/483/cerapedics-inc/3a5bc35c-a260-468c-b5da-ba534ee10fe5)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

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