FDA Inspection 1172848 — Carie Boyd Pharmaceuticals LLC
The FDA completed an inspection of Carie Boyd Pharmaceuticals LLC on Jun 27, 2022 in Irving, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 27, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 18009 | FDCA 503B(a)(10) | Container label, outsourcer facility |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21422 | FDCA 503B(b)(2)(A) | Outsourcing facility, compounded drug report follow up |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |