FDA Inspection
Ion Labs Inc.Ion Labs Inc. – FDA Inspection, Jun 3, 2011
Record Details
This FDA Inspection record concerns Ion Labs Inc., with an inspection on June 3, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ion Labs Inc.
- Inspection Date
- June 3, 2011
- Product Type
- Drugs
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ID · be1b6dd2-643e-4847-a015-1b38e2dadf81
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 727674
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
6- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.25(a)Procedures - calibrating instruments
- 21 CFR 111.260(j)Batch record - manufacture
- 21 CFR 111.90(c)Reprocessed batch - quality control approve
- 21 CFR 111.77(a)Specifications not met - reject, quality control
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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 |
| April 28, 2023 | VAI | Drug Quality Assurance | |
| 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 |
Other documents for Ion Labs Inc.
- FDA Inspection 1284972 - 2026-06-05
- FDA Inspection 1289294 - 2025-10-24
- FDA Inspection 1205742 - 2023-04-28
- FDA Inspection 1193487 - 2022-12-06
- FDA Inspection 987233 - 2016-05-12
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