FDA Inspection
VivaCeuticals, Inc. dba Regeneca WorldwideVivaCeuticals, Inc. dba Regeneca Worldwide – FDA Inspection, Sep 3, 2014
Record Details
This FDA Inspection record concerns VivaCeuticals, Inc. dba Regeneca Worldwide, with an inspection on September 3, 2014, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- September 3, 2014
- Product Type
- Food/cosmetics
View Company Profile
ID · 83363bea-1187-4b42-9a49-2ed2a72f6f36
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 897392
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
9- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.503Written procedures - returned dietary supplement
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - each batch
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Other FDA inspections of VivaCeuticals, Inc. dba Regeneca Worldwide
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2012 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| May 2, 2011 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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