FDA Inspection
Limber Prosthetics and Orthotics, IncLimber Prosthetics and Orthotics, Inc – FDA Inspection, Mar 20, 2026
Record Details
This FDA Inspection record concerns Limber Prosthetics and Orthotics, Inc, with an inspection on March 20, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.
- Inspection Date
- March 20, 2026
- Product Type
- Medical Devices & Rad Health
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ID · d7d96d4b-a870-46fa-bb01-950bdd1ffc45
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1309078
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- 21 CFR 830.310(b)GUDID Information required for unique device identification.
- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 4.1.6QMS software not validated prior to use or changes
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