FDA Inspection 1309078 — Limber Prosthetics and Orthotics, Inc
The FDA completed an inspection of Limber Prosthetics and Orthotics, Inc on March 20, 2026 in San Diego, CA. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 20, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22801 | 21 CFR 830.310(b) | GUDID Information required for unique device identification. |
| 23024 | ISO 13485:2016 Clause 4.1.5 | Inadequate monitoring and control over outsourced processes |
| 23028 | ISO 13485:2016 Clause 4.1.6 | QMS software not validated prior to use or changes |