FDA Inspection 809018 — Lumina Health Products, Inc.
The FDA completed an inspection of Lumina Health Products, Inc. on November 30, 2012 in Sarasota, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 30, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15589 | 21 CFR 111.160(c) | Packaging, labels - quarantine |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15903 | 21 CFR 111.87 | Material review, disposition - quality control |
| 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 |