FDA Inspection
Health Breakthroughs International LLCHealth Breakthroughs International LLC – FDA Inspection, Apr 18, 2013
Record Details
This FDA Inspection record concerns Health Breakthroughs International LLC, with an inspection on April 18, 2013, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- April 18, 2013
- Product Type
- Food/cosmetics
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ID · 5c5cc4b1-21cd-421f-8a91-ce6060646cc2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 828663
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
13- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.73Specifications met - identity, purity, strength, composition
- 21 CFR 111.25(b)Procedures - calibrating automated, mechanical equip
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
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Other FDA inspections of Health Breakthroughs International LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2012 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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