FDA Inspection
OraLabs LLCOraLabs LLC – FDA Inspection, Oct 2, 2025
Record Details
This FDA Inspection record concerns OraLabs LLC, with an inspection on October 2, 2025, issued by the Denver District Office, covering human drugs.
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ID · ac838430-fe26-4584-9b35-b7cff3725262
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1284290
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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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 |
| January 10, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 28, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 1114784 - 2020-01-10
- FDA Inspection 1090928 - 2019-05-28
- FDA Inspection 1061733 - 2018-07-13
- FDA Inspection 967035 - 2015-12-18
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