FDA Inspection 1258749 — WELLSKO LLC
The FDA completed an inspection of WELLSKO LLC on Dec 20, 2024 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 20, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Houston, TX (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 |
| 18281 | 21 CFR 1.505(a)(2) | Evaluation - performance, risk |
| 18290 | 21 CFR 1.506(a)(1) | Approved supplier procedures - importer established |
| 18291 | 21 CFR 1.506(a)(1) | Unapproved 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 |
| 18333 | 21 CFR 1.510(b)(1) | Record - available |