1218284
Higley Industries, Inc. — FEI 3002984417
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 21, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dyersville, IA (United States)
Citations
| ID | CFR | Description |
|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |