FDA Inspection 1280829 — Shire Nutraceuticals LLC
The FDA completed an inspection of Shire Nutraceuticals LLC on August 29, 2025 in Seminole, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 29, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Seminole, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15874 | 21 CFR 111.75(c)(4) | Documentation - specifications met; basis, quality control |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22886 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications, quality; packaging, labeling |