1268175
McGuff Pharmaceuticals, Inc. — FEI 2022073
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 28, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Ana, CA (United States)
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 |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 4576 | 21 CFR 211.192 | No written record of investigation |