FDA Inspection 1204109 — RADIANCE BEAUTY & WELLNESS INC.
The FDA completed an inspection of RADIANCE BEAUTY & WELLNESS INC. on April 28, 2023 in Chatsworth, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 28, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2005 | 21 CFR 211.184(e) | Records of disposition of rejected material |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |
| 2022 | 21 CFR 211.188(b)(10) | Documentation of Sampling Performed |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |