FDA Inspection
CC Wellness, LLCCC Wellness, LLC – FDA Inspection, Mar 21, 2018
Record Details
This FDA Inspection record concerns CC Wellness, LLC, with an inspection on March 21, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 62da3860-e9b7-4bf0-b8d0-9cb4cb74af77
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045232
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
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 |
| January 30, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for CC Wellness, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.