FDA Inspection
Agnitio IncAgnitio Inc – FDA Inspection, Aug 7, 2026
Record Details
This FDA Inspection record concerns Agnitio Inc, with an inspection on August 7, 2026, issued by the Minneapolis District Office, covering human drugs.
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ID · 5670a71a-994c-4cf1-9bc2-adbe8f1e2f99
Inspection Facts
- Inspection number
- 1332380
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
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Other FDA inspections of Agnitio Inc
4| 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 |
| July 19, 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
- FDA Inspection 1059372 - 2018-07-19
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