FDA Inspection 1258951 — Sani-Care Salon Products, Inc
The FDA completed an inspection of Sani-Care Salon Products, Inc on January 17, 2025 in Cartersville, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 17, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cartersville, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |