FDA Inspection 678739 — Blueroot Health, Inc.
The FDA completed an inspection of Blueroot Health, Inc. on September 2, 2010 in Middletown, CT. 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
- September 2, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Middletown, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15771 | 21 CFR 111.415(h) | Obsolete labels, packaging - dispose |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15875 | 21 CFR 111.75(d)(1) | Documentation specifications met; exempted, periodic testing |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |