FDA Inspection 795527 — Synergy Orthopaedic Systems, Inc
The FDA completed an inspection of Synergy Orthopaedic Systems, Inc on August 13, 2012 in Folsom, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 13, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Folsom, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12333 | 21 CFR 1271.170(b) | Not qualified, authorized for functions |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |
| 12362 | 21 CFR 1271.195(b) | Corrective actions |
| 12425 | 21 CFR 1271.265(c)(1) | Release of HCT/Ps by responsible person |