# FDA 483 - Burbank Dental Lab Inc - March 11, 2022

Source: https://www.globalkeysolutions.net/records/483/burbank-dental-lab-inc/74265b12-8e3c-419d-bd3e-6aef6ff5cfec

> FDA 483 for Burbank Dental Lab Inc on March 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Burbank Dental Lab Inc
- Inspection Date: 2022-03-11
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Burbank Dental Lab Inc, a Class II medical device contract manufacturer in Burbank, CA, revealed two significant observations. The firm failed to adequately maintain device history records, specifically lacking primary identification labels and labeling. Additionally, the company had not developed written Medical Device Reporting (MDR) procedures, including criteria for adverse events and reporting timeframes.

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.globalkeysolutions.net/companies/burbank-dental-lab-inc/9b3a688a-b229-4da2-9744-63d2c4b0a8d4

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6