1171544
FARMAKEIO OUTSOURCING LLC — FEI 3014982757
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 10, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Southlake, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 18009 | FDCA 503B(a)(10) | Container label, outsourcer facility |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |