1169044
ADVANCED THERACEUTICALS, LLC — FEI 3011165432
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 6, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Vestavia Hills, AL (United States)
Citations
| ID | CFR | Description |
|---|
| 15493 | 21 CFR 111.25(b) | Procedures - calibrating automated, mechanical equip |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15943 | 21 CFR 111.105(i) | QC required operations components packaging labels |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |