FDA Inspection 1159061 — Compound Preferred LLC
The FDA completed an inspection of Compound Preferred LLC on December 17, 2021 in Idaho Falls, ID. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 17, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Idaho Falls, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 18953 | FDCA 501(a)(2)(A) | Actionable microbial contamination, ISO 5 area |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |