767454
Risingsun Iodine Products Corp. — FEI 3005013963
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 16, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Livingston, MT (United States)
Citations
| ID | CFR | Description |
|---|
| 10005 | n/a | Procedural requirements |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15624 | 21 CFR 111.180(b)(3) | Documentation - components |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |