1175963
Frenda Corporation — FEI 3003945152
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 1, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Trujillo Alto, PR (United States)
Citations
| ID | CFR | Description |
|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |