# FDA 483 - Vynacron Dental Resins, Inc. - January 21, 2025

Source: https://www.keypedia.com/records/483/vynacron-dental-resins-inc/9e9d86c9-e9aa-4448-b4af-a8dafa752284

> FDA 483 for Vynacron Dental Resins, Inc. on January 21, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vynacron Dental Resins, Inc.
- Inspection Date: 2025-01-21
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Vynacron Dental Resins, Inc. in Jackson, NJ, a manufacturer of dental resins, revealed significant deficiencies in their quality system procedures. The firm was cited for inadequate procedures related to design change control, complaint handling, document control, and Medical Device Reporting (MDR). These observations indicate a need for comprehensive improvements in their quality management system.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/matthew-w-kyle/0f297104-ae6c-4fc4-a240-c84e5e907803)
- [Jaro P. Perera](https://www.keypedia.com/people/jaro-p-perera/5555676c-2151-4ecd-bad8-72a1ddab8936)
- [Shirley S. Wen](https://www.keypedia.com/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)

Company: https://www.keypedia.com/companies/vynacron-dental-resins-inc/24b687ed-86e1-4c15-b593-7a6fc7b25fb2

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248