1093172
Maitland Labs of Central Florida — FEI 3013854204
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 17, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 18009 | FDCA 503B(a)(10) | Container label, outsourcer facility |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |