# FDA 483 - OraLabs, Incorporated - December 18, 2015

Source: https://www.globalkeysolutions.net/records/483/oralabs-incorporated/a562bbc6-4b1a-409e-b5ee-68ac301dd075

> FDA 483 for OraLabs, Incorporated on December 18, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OraLabs, Incorporated
- Inspection Date: 2015-12-18
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of OraLabs, Incorporated, an OTC manufacturer in Parker, CO, revealed significant deficiencies in laboratory controls, equipment maintenance record-keeping, discrepancy investigations, and adherence to sampling and testing procedures. These issues indicate a lack of robust quality systems and control over drug product manufacturing and testing. The firm failed to adequately investigate rejected media, maintain complete equipment logs, review batch discrepancies, and follow correct testing methods.

## Related Documents

- [483 - 2020-01-10](https://www.globalkeysolutions.net/records/483/oralabs-incorporated/1dfc3a9e-f6ab-4b22-b458-0df6c08540b8)
- [483 - 2025-10-02](https://www.globalkeysolutions.net/records/483/oralabs-incorporated/2217adbf-296b-4a09-b938-83244437b689)

## Related Officers

- [Performance Improvement Coordinator](https://www.globalkeysolutions.net/people/tenzin-jangchup/733eb315-0eeb-40ce-af6d-03b406a9235d)
- [Jamie L. C. Dion](https://www.globalkeysolutions.net/people/jamie-l-c-dion/bea1370f-d56e-4eb1-8026-fcdec73d6eae)

Company: https://www.globalkeysolutions.net/companies/oralabs-incorporated/41e1dfcc-51f3-408c-984a-a59d0985d971

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face