FDA Inspection
Project CU Challenge UnlimitedProject CU Challenge Unlimited – FDA Inspection, Sep 3, 2015
Record Details
This FDA Inspection record concerns Project CU Challenge Unlimited, with an inspection on September 3, 2015, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- September 3, 2015
- Product Type
- Food/cosmetics
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ID · 1bf510f9-cdd7-4e33-b9ae-8c196ba85d10
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 942354
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
FDA Citations
5- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of Project CU Challenge Unlimited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2019 | Not classified | Kansas City District Office | |
| July 2, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 13, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Project CU Challenge Unlimited
- FDA Inspection 1087151 - 2019-03-28
- FDA Inspection 788928 - 2012-07-02
- FDA Inspection 638155 - 2010-01-13
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