FDA Inspection 1303426 — UNIS-BIO PHARMA LLC
The FDA completed an inspection of UNIS-BIO PHARMA LLC on February 17, 2026 in Carrollton, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 22848 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |