1251360
Specialty Formulations & Manufacturing, LLC — FEI 3008274683
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 12, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |