FDA Inspection 855659 — Vacunda & Design
The FDA completed an inspection of Vacunda & Design on October 29, 2013 in Camuy, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 29, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Camuy, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15431 | 21 CFR 111.15(e)(1) | Water supply - not component - suitability |
| 15480 | 21 CFR 111.20(h) | Physical plant - screening against pests |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15772 | 21 CFR 111.415(g) | Representative sample - packaged, labeled dietary supplement |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 16014 | 21 CFR 111.140(b)(1) | QC ops; written procedures; material review, disposition |
| 3709 | 21 CFR 110.80(a)(1) | Inspection of containers and carriers upon receipt |