FDA Inspection 1069961 — Exalt Medical
The FDA completed an inspection of Exalt Medical on Oct 23, 2018 in Austin, 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 23, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12372 | 21 CFR 1271.200(c) | Calibrated per established schedules |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |