FDA Inspection
U.S. Surgitech IncU.S. Surgitech Inc – FDA Inspection, Jul 9, 2024
Record Details
This FDA Inspection record concerns U.S. Surgitech Inc, with an inspection on July 9, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f4aea2cb-83bd-4fe5-9c5c-6c37b546b846
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1243400
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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