FDA Inspection
OraLabs LLCOraLabs LLC – FDA Inspection, May 28, 2019
Record Details
This FDA Inspection record concerns OraLabs LLC, with an inspection on May 28, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b5bc943e-fd9c-4cfc-8093-eab125a61c74
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1090928
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OraLabs LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2026 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| October 2, 2025 | OAI | Denver District Office | Drug Quality Assurance |
| January 10, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 18, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for OraLabs LLC
- FDA Inspection 1333886 - 2026-08-21
- FDA Inspection 1284290 - 2025-10-02
- FDA Inspection 1114784 - 2020-01-10
- FDA Inspection 1061733 - 2018-07-13
- FDA Inspection 967035 - 2015-12-18
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