FDA Inspection 1239914 — Bayshore Pharmaceuticals LLC
The FDA completed an inspection of Bayshore Pharmaceuticals LLC on May 23, 2024 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 23, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 18161 | 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 4464 | 21 CFR 108.25(c)(1) | Registration |