FDA Inspection 767086 — USPlabs, LLC
The FDA completed an inspection of USPlabs, LLC on February 21, 2012 in Dallas, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 21, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15801 | 21 CFR 111.560(b) | Quality control, review, approve; investigate, follow-up |
| 15820 | 21 CFR 111.55 | Production, process controls - packaged, labeled |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15935 | 21 CFR 111.105(d) | Quality control - basis; tests, examinations |
| 15938 | 21 CFR 111.105(f) | Quality control - representative samples |