FDA Inspection 855130 — USPlabs, LLC
The FDA completed an inspection of USPlabs, LLC on November 5, 2013 in Dallas, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 5, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15549 | 21 CFR 111.260(i) | Batch record - specifications |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15808 | 21 CFR 111.570(a) | Records - product complaints: readily available |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |