1119181
Maitland Labs of Central Florida — FEI 3013854204
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 28, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 18009 | FDCA 503B(a)(10) | Container label, outsourcer facility |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |