FDA Inspection 1211491 — Globo Pharma Inc
The FDA completed an inspection of Globo Pharma Inc on July 28, 2023 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 28, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15389 | 21 CFR 111.10(b)(1) | Outer garments |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15455 | 21 CFR 111.20(a) | Physical plant - size, construction, design |
| 15458 | 21 CFR 111.20(d)(1)(i) | Floors, walls, ceilings |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15742 | 21 CFR 111.210(h)(3) | Specific actions; packaged, labeled |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |