FDA Inspection
RINATI SKIN LLCRINATI SKIN LLC – FDA Inspection, Sep 22, 2022
Record Details
This FDA Inspection record concerns RINATI SKIN LLC, with an inspection on September 22, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- RINATI SKIN LLC
- Inspection Date
- September 22, 2022
- Product Type
- Drugs
View Company Profile
ID · 5764cb6e-8969-400b-8258-d06d7150518c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1180348
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
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