1216827
Biomic Sciences, LLC dba ION Intelligence of Nature — FEI 3012139887
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 31, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Charlottesville, VA (United States)
Citations
| ID | CFR | Description |
|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |