FDA Inspection 1098405 — Vicare International (USA) INC.
The FDA completed an inspection of Vicare International (USA) INC. on August 2, 2019 in Alhambra, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 2, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Alhambra, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |