FDA Inspection
Aurora Labs, LLCAurora Labs, LLC – FDA Inspection, Dec 3, 2021
Record Details
This FDA Inspection record concerns Aurora Labs, LLC, with an inspection on December 3, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aurora Labs, LLC
- Inspection Date
- December 3, 2021
- Product Type
- Drugs
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ID · 3e0a832f-94da-4f99-a33d-1c37acc1bd14
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1158401
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.165(a)Testing and release for distribution
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Other FDA inspections of Aurora Labs, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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