FDA Inspection
RADIANCE BEAUTY & WELLNESS INC.RADIANCE BEAUTY & WELLNESS INC. – FDA Inspection, Apr 28, 2023
Record Details
This FDA Inspection record concerns RADIANCE BEAUTY & WELLNESS INC., with an inspection on April 28, 2023, covering drugs.
- Inspection Date
- April 28, 2023
- Product Type
- Drugs
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ID · ea746a23-9ad9-4e78-82ae-238868d3ef2b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1204109
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.184(e)Records of disposition of rejected material
- 21 CFR 211.188(b)(10)Documentation of Sampling Performed
- 21 CFR 211.188(b)(2)Identification of Equipment and Lines
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of RADIANCE BEAUTY & WELLNESS INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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