# FDA 483 - Oceanic Dental Laboratory LLC - December 04, 2019

Source: https://www.keypedia.com/records/483/oceanic-dental-laboratory-llc/20667b81-10e1-4176-be39-7c23443ee8e4

> FDA 483 for Oceanic Dental Laboratory LLC on December 04, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oceanic Dental Laboratory LLC
- Inspection Date: 2019-12-04
- Product Type: device
- Office Name: Chicago District Office
- Summary: Oceanic Dental Laboratory LLC in Chicago, IL, was inspected from October to December 2019 and received a Form FDA 483 with six observations. The inspection revealed significant deficiencies in the firm's quality system, including a lack of established procedures for acceptance activities, process controls, process validation, corrective and preventive actions, supplier evaluation, and document control. These issues indicate a fundamental breakdown in the firm's ability to ensure product quality and compliance.

## Related Officers

- [Natasha R. Johnson](https://www.keypedia.com/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

Company: https://www.keypedia.com/companies/oceanic-dental-laboratory-llc/66c9fc0d-00e7-4361-bc85-2be02567a2d2

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669