FDA Inspection
Ionetix CorporationIonetix Corporation – FDA Inspection, Oct 31, 2025
Record Details
This FDA Inspection record concerns Ionetix Corporation, with an inspection on October 31, 2025, issued by the Kansas City District Office, covering human drugs.
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ID · 5c9b34a1-6c89-4161-93b9-ba815a4b0338
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1289498
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 212.50Adequate controls (general)
- 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.30(b)Equipment procedures
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Other FDA inspections of Ionetix Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 12, 2019 | VAI | Kansas City District Office | Generic Drug Evaluation |
Other documents for Ionetix Corporation
- FDA Inspection 1137344 - 2021-02-25
- FDA Inspection 1097847 - 2019-07-12
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