1123737
Allay Pharmaceuticals, LLC — FEI 3007007565
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 15, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hialeah, FL (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 |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |