FDA Inspection 1014709 — ForYou, Incorporated
The FDA completed an inspection of ForYou, Incorporated on May 3, 2017 in Loris, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 3, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Loris, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |