FDA Inspection 818989 — Jansen Enterprises, LLC
The FDA completed an inspection of Jansen Enterprises, LLC on March 1, 2013 in Minnetonka, MN. 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
- March 1, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Minnetonka, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15619 | 21 CFR 111.180(b)(1) | Written procedures - packaging, labeling received |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |