FDA Inspection
Eurofins Biolab S.r.l.Eurofins Biolab S.r.l. – FDA Inspection, Apr 18, 2018
Record Details
This FDA Inspection record concerns Eurofins Biolab S.r.l., with an inspection on April 18, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a3d20d2a-7039-44c7-af6c-05bb31d98ac1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049127
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.194(a)(5)Testing Calculations
- 21 CFR 211.188(b)(3)Identification of Components and In-Process Materials
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Eurofins Biolab S.r.l.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2024 | Not classified | Office of Inspections and Investigations | |
| June 25, 2024 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| October 5, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 21, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 20, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Eurofins Biolab S.r.l.
- FDA Inspection 1261441 - 2024-09-13
- FDA Inspection 1243943 - 2024-06-25
- FDA Inspection 1123754 - 2018-10-05
- FDA Inspection 929781 - 2015-05-21
- FDA Inspection 592212 - 2009-05-20
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