FDA Inspection 1031687 — Pine Creek General Store
The FDA completed an inspection of Pine Creek General Store on November 13, 2017 in Salem, AR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 13, 2017
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Salem, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15901 | 21 CFR 111.83(b)(3) | Reserve sample - retained |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |