FDA Inspection 696189 — United Nutrition Labs Inc
The FDA completed an inspection of United Nutrition Labs Inc on October 26, 2010 in Reedsville, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 26, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Reedsville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15468 | 21 CFR 111.20(c)(2) | Physical plant - material review and disposition |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15500 | 21 CFR 111.27(a)(2) | Equipment - design - no contamination |
| 15728 | 21 CFR 111.365(d) | Chemical, microbiological, other test-contaminated components |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15753 | 21 CFR 111.210(b) | Master manufacturing record - list components |
| 15775 | 21 CFR 111.415(e) | Dietary supplement containers - mix-ups |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15902 | 21 CFR 111.83(b)(4) | Reserve sample - twice the quantity |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15945 | 21 CFR 111.105(i) | QC - required operations packaging/labeling operations |
| 15972 | 21 CFR 111.120(b) | Quality control operations - specifications; components, packaging, labels |