FDA Inspection
Custompax, Inc., dba VitaganicCustompax, Inc., dba Vitaganic – FDA Inspection, Sep 25, 2014
Record Details
This FDA Inspection record concerns Custompax, Inc., dba Vitaganic, with an inspection on September 25, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 25, 2014
- Product Type
- Drugs
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ID · ee3f33ab-34af-4bfe-9db5-ec7a1da5ab2a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 897750
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
10- 21 CFR 111.210(h)(5)Corrective action plans
- 21 CFR 111.75(c)(2)Specifications met - test, examinations; compliance
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.70(c)(2)Specifications identity, purity strength, composition
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.210(a)Master manufacturing record - dietary ingredients
- 21 CFR 111.120(b)Quality control operations - specifications; components, packaging, labels
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Other FDA inspections of Custompax, Inc., dba Vitaganic
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 27, 2016 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 28, 2015 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| November 6, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 3, 2011 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 9, 2010 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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