FDA Inspection
Orthopedic Generations LLCOrthopedic Generations LLC – FDA Inspection, Sep 25, 2026
Record Details
This FDA Inspection record concerns Orthopedic Generations LLC, with an inspection on September 25, 2026, issued by the Chicago District Office, covering medical devices & rad health.
- Company
- Orthopedic Generations LLC
- Inspection Date
- September 25, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · a15613c2-85c1-4b67-b755-86674c009026
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1337614
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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