FDA Inspection
Oral Biotech, LLCOral Biotech, LLC – FDA Inspection, Oct 24, 2024
Record Details
This FDA Inspection record concerns Oral Biotech, LLC, with an inspection on October 24, 2024, issued by the Seattle District Office, covering human drugs.
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ID · ab6374c3-5dac-4163-aa99-e259da36cb59
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1252504
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Oral Biotech, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2026 | Not classified | Seattle District Office | Drug Quality Assurance |
| September 27, 2022 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| June 22, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 2, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 16, 2011 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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