FDA Inspection
Ion Labs Inc.Ion Labs Inc. – FDA Inspection, Apr 28, 2023
Record Details
This FDA Inspection record concerns Ion Labs Inc., with an inspection on April 28, 2023, covering drugs.
- Company
- Ion Labs Inc.
- Inspection Date
- April 28, 2023
- Product Type
- Drugs
View Company Profile
ID · 8d01d313-e8bf-4460-80c4-37b4ac2a8281
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1205742
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.63Equipment Design, Size and Location
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ion Labs Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2026 | Not classified | Florida District Office | |
| October 24, 2025 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| December 6, 2022 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 12, 2016 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| May 7, 2013 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Ion Labs Inc.
- FDA Inspection 1284972 - 2026-06-05
- FDA Inspection 1289294 - 2025-10-24
- FDA Inspection 1193487 - 2022-12-06
- FDA Inspection 987233 - 2016-05-12
- FDA Inspection 830653 - 2013-05-07
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