FDA Inspection 1081537 — Cade Medical, Inc.
The FDA completed an inspection of Cade Medical, Inc. on Mar 6, 2019 in Honolulu, HI. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 6, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Honolulu, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |