FDA Inspection
OraLabs LLCOraLabs LLC – FDA Inspection, Aug 11, 2010
Record Details
This FDA Inspection record concerns OraLabs LLC, with an inspection on August 11, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- OraLabs LLC
- Inspection Date
- August 11, 2010
- Product Type
- Drugs
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ID · e8b3e699-c681-4409-b750-86d791115aea
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 678668
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.186(b)(7)Theoretical Yield and Percentages
- 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 |
| October 2, 2025 | OAI | Denver District Office | Drug Quality Assurance |
| 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 |
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 1090928 - 2019-05-28
- FDA Inspection 1061733 - 2018-07-13
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