# FDA 483 - OraLabs, Incorporated - January 10, 2020

Source: https://www.keypedia.com/records/483/oralabs-incorporated/1dfc3a9e-f6ab-4b22-b458-0df6c08540b8

> FDA 483 for OraLabs, Incorporated on January 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OraLabs, Incorporated
- Inspection Date: 2020-01-10
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of OraLabs, Incorporated in Parker, CO, a manufacturer of drug products, revealed significant deficiencies across multiple systems. The firm failed to establish adequate laboratory controls, maintain equipment and facilities in a sanitary and good state of repair, and prevent contamination. Additionally, the quality control unit did not fully adhere to its responsibilities, leading to issues with CAPA implementation and inadequate investigations.

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

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