FDA Inspection
OraLabs LLCOraLabs LLC – FDA Inspection, Jan 10, 2020
Record Details
This FDA Inspection record concerns OraLabs LLC, with an inspection on January 10, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- OraLabs LLC
- Inspection Date
- January 10, 2020
- Product Type
- Drugs
View Company Profile
ID · 9a558c18-964a-48f9-aaeb-f8dd18b649f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1114784
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.56(b)Written sanitation procedures not followed
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 |
| 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 1284290 - 2025-10-02
- FDA Inspection 1090928 - 2019-05-28
- FDA Inspection 1061733 - 2018-07-13
- FDA Inspection 967035 - 2015-12-18
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