FDA Inspection 1112515 — OFE Fulfillment, Inc.
The FDA completed an inspection of OFE Fulfillment, Inc. on December 12, 2019 in Mooresville, NC. 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
- December 12, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Mooresville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15493 | 21 CFR 111.25(b) | Procedures - calibrating automated, mechanical equip |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15653 | 21 CFR 111.470 | Distribute dietary supplement; contamination, deterioration |
| 15801 | 21 CFR 111.560(b) | Quality control, review, approve; investigate, follow-up |
| 15946 | 21 CFR 111.105(i) | QC - required operations returned dietary supplements |