FDA Inspection 782128 — CocoKefir, LLC
The FDA completed an inspection of CocoKefir, LLC on May 15, 2012 in Medina, MN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 15, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Medina, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15834 | 21 CFR 111.70(c)(2) | Specifications identity, purity strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16014 | 21 CFR 111.140(b)(1) | QC ops; written procedures; material review, disposition |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |