FDA Inspection
Oral Biotech, LLCOral Biotech, LLC – FDA Inspection, Apr 2, 2015
Record Details
This FDA Inspection record concerns Oral Biotech, LLC, with an inspection on April 2, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Oral Biotech, LLC
- Inspection Date
- April 2, 2015
- Product Type
- Devices
View Company Profile
ID · 4e2fb971-24d5-44e6-b2fd-8af40fe23669
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 921337
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(c)Management review dates
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Oral Biotech, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2026 | Not classified | Seattle District Office | Drug Quality Assurance |
| October 24, 2024 | VAI | 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 |
| August 16, 2011 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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