FDA Inspection
BioAgilytixBioAgilytix – FDA Inspection, Mar 2, 2018
Record Details
This FDA Inspection record concerns BioAgilytix, with an inspection on March 2, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Amanda Lewin (Issuing Officer)
- Melkamu Getie Kebtie (Issuing Officer)
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ID · 9062b407-edbe-4d7b-8805-b846563ac74d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049402
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
Other FDA inspections of BioAgilytix
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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