FDA Inspection 1293976 — The Harvard Drug Group LLC
The FDA completed an inspection of The Harvard Drug Group LLC on March 20, 2026 in La Vergne, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 20, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- La Vergne, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |