FDA Inspection
Agnitio IncAgnitio Inc – FDA Inspection, Nov 9, 2018
Record Details
This FDA Inspection record concerns Agnitio Inc, with an inspection on November 9, 2018, issued by the Minneapolis District Office, covering human drugs.
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ID · 2c56e945-ad0b-4c2a-bbd0-ff49e367246e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071299
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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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 |
| 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 1059372 - 2018-07-19
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