FDA Inspection 1167397 — EarthLab Holdings Inc
The FDA completed an inspection of EarthLab Holdings Inc on April 14, 2022 in Creswell, OR. 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
- April 14, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Creswell, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15784 | 21 CFR 111.410(c) | Packaging, labels - master manufacturing record |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16085 | 21 CFR 111.75(c)(3) | Specifications met limits on contamination ; basis |