990072
Cantrell Drug Company — FEI 3004483441
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 14, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Little Rock, AR (United States)
Citations
| ID | CFR | Description |
|---|
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 18008 | FDCA 503B(a)(10) | Drug product 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 |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |