FDA Inspection 1081647 — Lexia LLC
The FDA completed an inspection of Lexia LLC on March 7, 2019 in Franklin, TN. 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
- March 7, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Franklin, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1770 | 21 CFR 211.137(d) | Expiration date location on labeling |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |