# FDA 483 - Ceragroup Industries Inc - April 15, 2025

Source: https://www.keypedia.com/records/483/ceragroup-industries-inc/896542a6-a182-4230-89dc-36db3e6f4c97

> FDA 483 for Ceragroup Industries Inc on April 15, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ceragroup Industries Inc
- Inspection Date: 2025-04-15
- Product Type: device
- Office Name: Florida District Office
- Summary: Ceragroup Industries Inc., a medical device manufacturer in Fort Lauderdale, FL, was cited with two observations during an FDA inspection. The firm failed to adequately establish and follow procedures for corrective and preventive actions, with multiple CAPAs remaining open without verification or validation. Additionally, the firm's purchasing controls were found deficient, as it accepted raw materials for its Class II medical devices without required Certificates of Conformance or Analysis.

## Related Documents

- [483 - 2022-10-11](https://www.keypedia.com/records/483/ceragroup-industries-inc/b6f0cd71-0f60-4cfd-9ee6-d7e44eb7cd75)

## Related Officers

- [Marvin A. Marenco](https://www.keypedia.com/people/marvin-a-marenco/b4638545-ba1f-4b1c-940f-7c18c5f436ed)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9