FDA Inspection 1291714 — GRAMERCY EXTREMITY ORTHOPEDICS
The FDA completed an inspection of GRAMERCY EXTREMITY ORTHOPEDICS on Oct 24, 2025 in Richardson, 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 24, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Richardson, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |