# FDA 483 - C4 Imaging LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/c4-imaging-llc/e846c2a1-43a4-4202-a732-494c774f1a46

> FDA 483 for C4 Imaging LLC on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: C4 Imaging LLC
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Chongqing LLC, a device manufacturer in Bellaire, TX, was inspected by the FDA, revealing significant deficiencies in its quality system. The firm failed to conduct and document required management reviews and internal quality audits. Additionally, evaluations of potential suppliers were not documented according to established procedures.

## Related Documents

- [483 - 2019-05-17](https://www.globalkeysolutions.net/records/483/c4-imaging-llc/bd2a14d0-e937-4429-9d4a-e57f50fe8cdc)

## Related Officers

- [Amber Smith](https://www.globalkeysolutions.net/people/amber-smith/2395fa1b-d091-4227-a340-9d6991c394fa)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab