1143441
Bell-More Labs, Inc. — FEI 1150023
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 7, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hampstead, MD (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1430 | 21 CFR 211.42(c)(10)(i) | Floors, walls, ceiling surfaces |
| 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 |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |