FDA Inspection 964163 — ProSupps USA, LLC
The FDA completed an inspection of ProSupps USA, LLC on March 14, 2016 in Plano, 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
- March 14, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Plano, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15771 | 21 CFR 111.415(h) | Obsolete labels, packaging - dispose |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16004 | 21 CFR 111.130(b) | Quality control operations -returned dietary supplement; salvage, redistribution |
| 16046 | 21 CFR 111.503 | Written procedures returned dietary supplement investigation |
| 16047 | 21 CFR 111.510 | Returned dietary supplement - material review, disposition |