FDA Inspection
Pathright Medical IncPathright Medical Inc – FDA Inspection, Nov 17, 2025
Record Details
This FDA Inspection record concerns Pathright Medical Inc, with an inspection on November 17, 2025, issued by the Denver District Office, covering medical devices & rad health.
- Company
- Pathright Medical Inc
- Inspection Date
- November 17, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 4745af2f-0396-4918-9cb9-6ca97307325f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1291616
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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