1214994
Pure Simple Products aka Northern Elderberry — FEI 3016418266
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 16, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Traverse City, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 4464 | 21 CFR 108.25(c)(1) | Registration |