1275888
Fulijaya Manufacturing SDN. BHD. — FEI 1000291174
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 18, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kulim (Malaysia)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |