FDA Inspection 1041970 — Ortho & Surgical Solutions, Inc.
The FDA completed an inspection of Ortho & Surgical Solutions, Inc. on February 1, 2018 in Guaynabo, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 1, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Guaynabo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12437 | 21 CFR 1271.270(a) | Records incomplete |