FDA Inspection
Db Lab A/SDb Lab A/S – FDA Inspection, Aug 30, 2019
Record Details
This FDA Inspection record concerns Db Lab A/S, with an inspection on August 30, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 2a6d0c36-af8f-425b-8b82-f611070a5028
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101046
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Db Lab A/S
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 21, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Db Lab A/S
- FDA Inspection 1272812 - 2023-08-16
- FDA Inspection 1095010 - 2019-02-21
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