FDA Inspection 829888 — We Make Vitamins LLC
The FDA completed an inspection of We Make Vitamins LLC on April 25, 2013 in Lakeland, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 25, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lakeland, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15493 | 21 CFR 111.25(b) | Procedures - calibrating automated, mechanical equip |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15951 | 21 CFR 111.110(c) | Quality control operations - tests, examinations; results |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |