FDA Inspection 1214994 — Pure Simple Products Aka Northern Elderberry
The FDA completed an inspection of Pure Simple Products Aka Northern Elderberry on Aug 16, 2023 in Traverse City, MI. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 16, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- 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 |