FDA Inspection 1254560 — Ekos America, Inc.
The FDA completed an inspection of Ekos America, Inc. on November 19, 2024 in Brooklyn, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 19, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Brooklyn, NY (United States)
Additional Details
FSVP
Citations
| ID | CFR | Description |
|---|---|---|
| 18262 | 21 CFR 1.504(a) | Hazard analysis written |
| 18288 | 21 CFR 1.505(d) | Evaluation, reevaluation - another entity |
| 18292 | 21 CFR 1.506(a)(2) | Approved supplier procedures- another entity |
| 18334 | 21 CFR 1.510(b)(1) | Record - translate to English |