FDA Inspection 1081171 — Elevate Surgical Co
The FDA completed an inspection of Elevate Surgical Co on March 4, 2019 in Honolulu, HI. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 4, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Honolulu, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12412 | 21 CFR 1271.260(b) | Storage temperatures appropriate |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |