FDA Inspection 775487 — Mushroom Wisdom, Inc.
The FDA completed an inspection of Mushroom Wisdom, Inc. on April 30, 2012 in East Rutherford, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 30, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- East Rutherford, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15712 | 21 CFR 111.325(b)(2)(ii) | Records - document; results |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |