FDA Inspection
Vitamins Direct (USA), Inc.Vitamins Direct (USA), Inc. – FDA Inspection, Jan 23, 2019
Record Details
This FDA Inspection record concerns Vitamins Direct (USA), Inc., with an inspection on January 23, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · b98fbf94-ddd3-4f11-9a7d-da3db7459e75
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078400
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.75(a)(2)(ii)(D)Re-confirm certificate of analysis
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Other FDA inspections of Vitamins Direct (USA), Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2016 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| August 14, 2013 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| August 14, 2013 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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