FDA Inspection
Geneva Laboratories, IncGeneva Laboratories, Inc – FDA Inspection, Apr 5, 2018
Record Details
This FDA Inspection record concerns Geneva Laboratories, Inc, with an inspection on April 5, 2018, issued by the Minneapolis District Office, covering medical devices & rad health.
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ID · 89670481-1746-4c31-b7e2-d64325a53de0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046966
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 58.29(a)Personnel: education, training, experience
- 21 CFR 58.35(a)QAU: separate and independent
- 21 CFR 58.35(b)(3)QAU: inspect study at adequate intervals
- 21 CFR 58.63(a)Equipment: calibration
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Other FDA inspections of Geneva Laboratories, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2025 | VAI | Minneapolis District Office | Drug Quality Assurance |
| June 3, 2021 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 11, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 30, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 6, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Geneva Laboratories, Inc
- FDA Inspection 1290960 - 2025-11-04
- FDA Inspection 1143396 - 2021-06-03
- FDA Inspection 930535 - 2015-06-11
- FDA Inspection 761091 - 2011-12-30
- FDA Inspection 664201 - 2010-05-06
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