FDA Inspection 1203394 — New Royal Distributors
The FDA completed an inspection of New Royal Distributors on May 12, 2023 in Addison, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 12, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Addison, IL (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 |
| 18263 | 21 CFR 1.504(b)(1) | Hazard analysis biological, chemical, physical |
| 18281 | 21 CFR 1.505(a)(2) | Evaluation - performance, risk |
| 18290 | 21 CFR 1.506(a)(1) | Approved supplier procedures - importer established |
| 18293 | 21 CFR 1.506(b) | Supplier verification - establish written procedures |
| 18295 | 21 CFR 1.506(d)(1)(i) | Verification activity assurance |
| 18296 | 21 CFR 1.506(d)(1)(i) | Verification activity frequency |
| 18299 | 21 CFR 1.506(d)(1)(ii) | Verification activity - appropriate |
| 18303 | 21 CFR 1.506(e)(1) | Verification activity before import, periodically |