FDA Inspection
Aurena Laboratories ABAurena Laboratories AB – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns Aurena Laboratories AB, with an inspection on September 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f28f15be-b218-46aa-8d5c-153662df57c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101986
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.170(b)Reserve drug product sample quantity - all tests
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.166(a)(1)Sample size - test intervals
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Aurena Laboratories AB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aurena Laboratories AB
- FDA Inspection 972344 - 2016-06-01
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