FDA Inspection 815713 — PurQuality, LLC
The FDA completed an inspection of PurQuality, LLC on January 23, 2013 in Tempe, AZ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 23, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tempe, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15755 | 21 CFR 111.205(c) | Master manufacturing record: readily available |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15951 | 21 CFR 111.110(c) | Quality control operations - tests, examinations; results |