FDA Inspection
Ionetix CorporationIonetix Corporation – FDA Inspection, Jul 12, 2019
Record Details
This FDA Inspection record concerns Ionetix Corporation, with an inspection on July 12, 2019, issued by the Kansas City District Office, covering human drugs.
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ID · 31b54cf0-6673-4711-babd-adfa4015dc3b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097847
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.50Adequate controls (general)
- 21 CFR 212.60(c)Analytical methods
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Other FDA inspections of Ionetix Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2025 | VAI | Kansas City District Office | Drug Quality Assurance |
| February 25, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ionetix Corporation
- FDA Inspection 1289498 - 2025-10-31
- FDA Inspection 1137344 - 2021-02-25
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