FDA Inspection
Aurora Labs, LLCAurora Labs, LLC – FDA Inspection, Aug 10, 2016
Record Details
This FDA Inspection record concerns Aurora Labs, LLC, with an inspection on August 10, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aurora Labs, LLC
- Inspection Date
- August 10, 2016
- Product Type
- Drugs
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ID · e3b4ef44-b336-4f27-8332-8f4ebcccd767
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 982747
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.160(b)(2)In-process samples representative, identified properly
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Other FDA inspections of Aurora Labs, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 3, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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