FDA Inspection
CC Wellness, LLCCC Wellness, LLC – FDA Inspection, Jan 30, 2014
Record Details
This FDA Inspection record concerns CC Wellness, LLC, with an inspection on January 30, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- CC Wellness, LLC
- Inspection Date
- January 30, 2014
- Product Type
- Drugs
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ID · bb283df2-c450-45ed-8a9f-0b9c6572c3e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 863188
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 820.100(b)Documentation
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
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Other FDA inspections of CC Wellness, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2026 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| November 15, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 2, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 21, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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