FDA Inspection 1247233 — Sweet's Elderberry, LLC
The FDA completed an inspection of Sweet's Elderberry, LLC on Aug 22, 2024 in Charlotte, NC. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 22, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 3082 | 21 CFR 114.89 | Process deviation |
| 3090 | 21 CFR 114.100(d) | Product distribution |