FDA Inspection 1268175 — McGuff Pharmaceuticals, Inc.
The FDA completed an inspection of McGuff Pharmaceuticals, Inc. on Apr 28, 2025 in Santa Ana, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 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 |