FDA Inspection 998127 — Mannatech Inc
The FDA completed an inspection of Mannatech Inc on January 13, 2017 in Flower Mound, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 13, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Flower Mound, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |