FDA Inspection 650336 — Lotus Light Enterprises, Inc
The FDA completed an inspection of Lotus Light Enterprises, Inc on April 8, 2010 in Silver Lake, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 8, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Silver Lake, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15771 | 21 CFR 111.415(h) | Obsolete labels, packaging - dispose |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |