FDA Inspection
OraLabs LLCOraLabs LLC – FDA Inspection, Nov 23, 2011
Record Details
This FDA Inspection record concerns OraLabs LLC, with an inspection on November 23, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- OraLabs LLC
- Inspection Date
- November 23, 2011
- Product Type
- Drugs
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ID · 3a1a61f3-e0c3-4a0c-bda9-fab579c913d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756796
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.180(e)(1)Review of representative number of batches
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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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