FDA Inspection 1267091 — LINKONE INC
The FDA completed an inspection of LINKONE INC on April 17, 2025 in Fullerton, 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
- April 17, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Fullerton, CA (United States)
Additional Details
FSVP
Citations
| ID | CFR | Description |
|---|---|---|
| 18254 | 21 CFR 1.502(a) | Develop FSVP |
| 18328 | 21 CFR 1.509(a) | Identification - entry |
| 18366 | 21 CFR 1.511(c)(1) | No CGMPs - supplier approval, performance, risk |
| 18388 | 21 CFR 1.511(c)(2)(i) | No CGMPs - approval procedures |
| 18392 | 21 CFR 1.511(c)(3) | No CGMPs - verification activities, procedures |