FDA Inspection 1241822 — Carie Boyd Pharmaceuticals LLC
The FDA completed an inspection of Carie Boyd Pharmaceuticals LLC on Jun 21, 2024 in Irving, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 21, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |