FDA Inspection 931579 — Formulife, LLC
The FDA completed an inspection of Formulife, LLC on July 23, 2015 in Allen, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 23, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Allen, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15594 | 21 CFR 111.160(c)(2) | Packaging - quality control; tests, examination |
| 15597 | 21 CFR 111.160(c)(3) | Labels - quality control; approve, release |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |