FDA Inspection 1250064 — Formulife, LLC
The FDA completed an inspection of Formulife, LLC on December 9, 2024 in Allen, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 9, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Allen, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 3067 | 21 CFR 114.80(a) | Quality control procedures |
| 4464 | 21 CFR 108.25(c)(1) | Registration |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 4511 | 21 CFR 108.25(f) | Approved school |