# FDA 483 - C4 Imaging LLC - May 17, 2019

Source: https://www.keypedia.com/records/483/c4-imaging-llc/bd2a14d0-e937-4429-9d4a-e57f50fe8cdc

> FDA 483 for C4 Imaging LLC on May 17, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: C4 Imaging LLC
- Inspection Date: 2019-05-17
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: C4 Imaging LLC, a medical device manufacturer in Doylestown, PA, was inspected by the FDA on May 17, 2019. The inspection revealed significant deficiencies in the firm's quality system, specifically the absence of written procedures for Medical Device Reporting (MDR) and for corrective and preventive actions. These issues indicate a fundamental lack of established processes for critical quality system elements.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/c4-imaging-llc/e846c2a1-43a4-4202-a732-494c774f1a46)

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.keypedia.com/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.keypedia.com/companies/c4-imaging-llc/16d89b68-9023-416c-840c-95506de0826a

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8