# OraLabs LLC – FDA 483, Jan 10, 2020

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

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

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## Details

- Record Type: 483
- Company Name: OraLabs LLC
- 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.

## Related Documents

- [483 - 2025-10-02](https://www.keypedia.com/records/483/oralabs-llc/2217adbf-296b-4a09-b938-83244437b689) — date: October 2, 2025
- [EIR - 2020-01-10](https://www.keypedia.com/records/eir/oralabs-llc/a597e3ce-ecfc-470c-badb-4039f29fb40f) — date: January 10, 2020
- [EIR - 2018-07-13](https://www.keypedia.com/records/eir/oralabs-llc/d1945398-5546-41f0-b2f5-608c86ab15bb) — date: July 13, 2018
- [483 - 2015-12-18](https://www.keypedia.com/records/483/oralabs-llc/a562bbc6-4b1a-409e-b5ee-68ac301dd075) — date: December 18, 2015

## Related Officers

- [Investigator](https://www.keypedia.com/people/lisa-shin/13c87687-fe3d-41a5-8973-42be901a5b0c)
- [investigator](https://www.keypedia.com/people/ian-m-carrico/1b223bd4-9f17-4d92-839d-f7ef890744dc)
- [SVP Consulting & Operations](https://www.keypedia.com/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

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

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