FDA Inspection 635812 — United Nutrition Labs Inc
The FDA completed an inspection of United Nutrition Labs Inc on December 14, 2009 in Reedsville, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 14, 2009
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Reedsville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15509 | 21 CFR 111.27(a)(6) | Instruments, controls - accurate, precise, maintained |
| 15592 | 21 CFR 111.160(c)(1) | Packaging - visual identification; containers, closures |
| 15619 | 21 CFR 111.180(b)(1) | Written procedures - packaging, labeling received |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15784 | 21 CFR 111.410(c) | Packaging, labels - master manufacturing record |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15955 | 21 CFR 111.113(a)(3) | Quality control - adulteration; material review, disposition |
| 16007 | 21 CFR 111.135 | Quality control operations - product complaints |