FDA Inspection 1248416 — SmartSurg Medical Supply LLC
The FDA completed an inspection of SmartSurg Medical Supply LLC on Aug 29, 2024 in Dallas, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 29, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12415 | 21 CFR 1271.260(e) | Temperature limits |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |