1081816
Hello Life, Inc — FEI 3009727070
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 7, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grand Rapids, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 15380 | 21 CFR 111.8 | Written procedures - sick or infected personnel |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15429 | 21 CFR 111.15(k) | Sanitation supervisors - assigned |
| 15598 | 21 CFR 111.160(d)(1) | Packaging - identify |
| 15799 | 21 CFR 111.560(a)(1) | Product complaint - quality control review |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |
| 15999 | 21 CFR 111.127(h) | Quality control operations - packaging, labeling; approving, rejecting |
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |