FDA Inspection
Agnitio IncAgnitio Inc – FDA Inspection, Jul 19, 2018
Record Details
This FDA Inspection record concerns Agnitio Inc, with an inspection on July 19, 2018, issued by the Minneapolis District Office, covering human drugs.
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ID · 6afe22f8-1834-4baa-815d-6577357bb3f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1059372
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Agnitio Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 4, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2018 | VAI | Minneapolis District Office | Generic Drug Evaluation |
Other documents for Agnitio Inc
- FDA Inspection 1295362 - 2025-11-21
- FDA Inspection 1146649 - 2021-06-04
- FDA Inspection 1071299 - 2018-11-09
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