FDA Inspection
Sani-Care Salon Products, IncSani-Care Salon Products, Inc – FDA Inspection, Nov 3, 2023
Record Details
This FDA Inspection record concerns Sani-Care Salon Products, Inc, with an inspection on November 3, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d3d22136-964b-44fe-85b1-e9a647e52e15
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1222364
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
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Other FDA inspections of Sani-Care Salon Products, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2025 | OAI | Atlanta District Office | Drug Quality Assurance |
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