FDA Inspection
Lyocontract GmbHLyocontract GmbH – FDA Inspection, May 25, 2023
Record Details
This FDA Inspection record concerns Lyocontract GmbH, with an inspection on May 25, 2023, issued by the Office of Inspections and Investigations.
- Company
- Lyocontract GmbH
- Inspection Date
- May 25, 2023
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ID · 414d2ea9-9a61-42ca-8ccd-3ac984757704
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1206630
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.63Equipment Design, Size and Location
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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 |
| September 20, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 13, 2018 | VAI | Office of Inspections and Investigations | New Drug Evaluation |
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