FDA Inspection 1202638 — Sanitor Corporation
The FDA completed an inspection of Sanitor Corporation on April 14, 2023 in Stanton, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 14, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Stanton, CA (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 |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |