FDA Inspection 732571 — Sarati International, Inc
The FDA completed an inspection of Sarati International, Inc on Jun 29, 2011 in Los Fresnos, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 29, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Los Fresnos, TX (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 |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |