FDA Inspection
Wellki, LLCWellki, LLC – FDA Inspection, Mar 28, 2013
Record Details
This FDA Inspection record concerns Wellki, LLC, with an inspection on March 28, 2013, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Wellki, LLC
- Inspection Date
- March 28, 2013
- Product Type
- Food/cosmetics
View Company Profile
ID · 2c3cb6f6-7c78-4472-9073-66c93f1b03e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 824492
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
8- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.95(b)(2)Documentation - supplier qualification
- 21 CFR 111.95(b)(1)Records - established specifications
- 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.12(b)Personnel - quality control operations; identified
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Wellki, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2014 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Wellki, LLC
- FDA Inspection 889963 - 2014-08-06
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