FDA Inspection
Promeko, Inc.Promeko, Inc. – FDA Inspection, Nov 21, 2013
Record Details
This FDA Inspection record concerns Promeko, Inc., with an inspection on November 21, 2013, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Promeko, Inc.
- Inspection Date
- November 21, 2013
- Product Type
- Food/cosmetics
View Company Profile
ID · 4360c693-d920-4cc6-aded-ff5a741e850a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 858056
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
6- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 111.65Quality control - quality, dietary supplement
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Promeko, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2019 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| October 17, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 30, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Promeko, Inc.
- FDA Inspection 1109716 - 2019-11-05
- FDA Inspection 995397 - 2016-10-17
- FDA Inspection 739400 - 2011-08-30
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