FDA Inspection 1109032 — Green Water, LLC
The FDA completed an inspection of Green Water, LLC on November 6, 2019 in Conifer, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 19 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 6, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Conifer, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15493 | 21 CFR 111.25(b) | Procedures - calibrating automated, mechanical equip |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15741 | 21 CFR 111.210(h)(3)(i) | Components, verify weight, measure |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 16047 | 21 CFR 111.510 | Returned dietary supplement - material review, disposition |