FDA Inspection
Reneu Concepts CorporationReneu Concepts Corporation – FDA Inspection, Nov 9, 2017
Record Details
This FDA Inspection record concerns Reneu Concepts Corporation, with an inspection on November 9, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Courtney R. Ingalsbe (Issuing Officer)
- Margaret M. Lubbers-Solberg (Issuing Officer)
View Company Profile
ID · a4177c72-2542-4f5a-a03c-69c0a0c91939
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031088
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.453Written procedures - holding
- 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 111.610(a)Records - available; FDA
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.255(b)Batch record - complete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Reneu Concepts Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2021 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| October 16, 2012 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Reneu Concepts Corporation
- FDA Inspection 1146612 - 2021-07-19
- FDA Inspection 805172 - 2012-10-16
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