FDA Inspection
5N Plus Lubeck GmbH5N Plus Lubeck GmbH – FDA Inspection, Nov 9, 2018
Record Details
This FDA Inspection record concerns 5N Plus Lubeck GmbH, with an inspection on November 9, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f105813d-bea2-46e4-ba2c-94dae4d74211
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074936
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of 5N Plus Lubeck GmbH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 7, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for 5N Plus Lubeck GmbH
- FDA Inspection 1287750 - 2023-04-27
- FDA Inspection 937613 - 2015-08-07
- FDA Inspection 792591 - 2012-07-26
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