FDA Inspection 1172684 — Manzela USA, LLC
The FDA completed an inspection of Manzela USA, LLC on June 24, 2022 in Mcallen, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 24, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Mcallen, TX (United States)
Additional Details
FSVP
Citations
| ID | CFR | Description |
|---|---|---|
| 18254 | 21 CFR 1.502(a) | Develop FSVP |
| 18281 | 21 CFR 1.505(a)(2) | Evaluation - performance, risk |
| 18286 | 21 CFR 1.505(c)(2) | Reevaluate - 3 years |
| 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 |
| 18303 | 21 CFR 1.506(e)(1) | Verification activity before import, periodically |