# FDA 483 - Ceragroup Industries Inc - October 11, 2022

Source: https://www.globalkeysolutions.net/records/483/ceragroup-industries-inc/b6f0cd71-0f60-4cfd-9ee6-d7e44eb7cd75

> FDA 483 for Ceragroup Industries Inc on October 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ceragroup Industries Inc
- Inspection Date: 2022-10-11
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Ceragroup Industries Inc, a medical device manufacturer of dental porcelain powders and pastes in Fort Lauderdale, FL, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, particularly concerning corrective and preventive actions, equipment calibration, management review procedures, and supplier evaluation. These issues indicate a lack of adequate control over critical manufacturing processes and quality management.

## Related Documents

- [483 - 2025-04-15](https://www.globalkeysolutions.net/records/483/ceragroup-industries-inc/896542a6-a182-4230-89dc-36db3e6f4c97)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.globalkeysolutions.net/companies/ceragroup-industries-inc/3f9fa477-b335-4ef0-8997-adf1495976a3

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6