1062824
Bayscience Formulators, LLC — FEI 3006210508
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 9, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dudley, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |