FDA Inspection 1165915 — Sanitizer Supply LLC
The FDA completed an inspection of Sanitizer Supply LLC on March 31, 2022 in Suwanee, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 31, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Suwanee, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |