FDA Inspection 676027 — Wildly Organic, LLC
The FDA completed an inspection of Wildly Organic, LLC on July 30, 2010 in Silver Bay, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 30, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Silver Bay, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15561 | 21 CFR 111.260(k)(3) | Batch record - tests, examinations; results |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15608 | 21 CFR 111.165(c)(3) | Product received - quality control; approve |
| 15618 | 21 CFR 111.180(b)(1) | Written procedures - components |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15768 | 21 CFR 111.420(c) | Repackaged, relabeled - quality control: approve, rejects |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16037 | 21 CFR 111.605 | Records - keep: 1 year, 2 years |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |