FDA Inspection 1269949 — ORAS 2 INC
The FDA completed an inspection of ORAS 2 INC on May 5, 2025 in Sterling Heights, MI. 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
- May 5, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Sterling Heights, MI (United States)
Additional Details
FSVP
Citations
| ID | CFR | Description |
|---|---|---|
| 18254 | 21 CFR 1.502(a) | Develop FSVP |
| 18262 | 21 CFR 1.504(a) | Hazard analysis written |
| 18272 | 21 CFR 1.504(d) | Document review entity's hazard analysis |
| 18303 | 21 CFR 1.506(e)(1) | Verification activity before import, periodically |