FDA Inspection
Lyocontract GmbHLyocontract GmbH – FDA Inspection, Jul 13, 2018
Record Details
This FDA Inspection record concerns Lyocontract GmbH, with an inspection on July 13, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 0980c799-e53c-4395-96cf-d1f9605eefb8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1058786
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.198(a)Adverse Drug Experience
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Other FDA inspections of Lyocontract GmbH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 25, 2023 | VAI | Office of Inspections and Investigations | |
| September 20, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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