FDA Inspection 887210 — Montana Emu Ranch Company
The FDA completed an inspection of Montana Emu Ranch Company on June 14, 2014 in Kalispell, MT. 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
- June 14, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Kalispell, MT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15352 | FDCA 761(b)(1) | No label copy submitted with AE report (dietary supplement) |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15572 | 21 CFR 111.153 | Written procedures - labels |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15891 | 21 CFR 111.80(a) | Components packaging, labels received |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |