FDA Inspection 767315 — PurQuality, LLC
The FDA completed an inspection of PurQuality, LLC on January 30, 2012 in Tempe, AZ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 30, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tempe, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15511 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 15672 | 21 CFR 111.315 | Laboratory control processes - reviewed, approved |
| 15673 | 21 CFR 111.315(a) | Criteria for establishing specifications |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15683 | 21 CFR 111.315(c) | Examination, testing methods; criteria for selecting |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |