FDA Inspection
Oral Biotech, LLCOral Biotech, LLC – FDA Inspection, Sep 25, 2026
Record Details
This FDA Inspection record concerns Oral Biotech, LLC, with an inspection on September 25, 2026, issued by the Seattle District Office, covering human drugs.
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ID · 0a1c1273-fc50-439e-a8e5-9d868a653694
Inspection Facts
- Inspection number
- 1338424
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Oral Biotech, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| 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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