FDA Inspection 933846 — Rocky Fork Formulas Inc
The FDA completed an inspection of Rocky Fork Formulas Inc on July 8, 2015 in Newark, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 8, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Newark, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 16017 | 21 CFR 111.140(b)(3) | Records - material review, disposition documentation |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |