FDA Inspection 1112611 — Rocky Fork Formulas Inc
The FDA completed an inspection of Rocky Fork Formulas Inc on December 12, 2019 in Newark, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 12, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Newark, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15999 | 21 CFR 111.127(h) | Quality control operations - packaging, labeling; approving, rejecting |
| 16016 | 21 CFR 111.140(b)(2)(ii) | Signature; review, approval, rejection; reprocessing |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |