FDA Inspection 1251850 — Kavis Pharma LLC
The FDA completed an inspection of Kavis Pharma LLC on Apr 9, 2025 in Sugar Land, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 9, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sugar Land, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |