FDA Inspection
ZIIP INCZIIP INC – FDA Inspection, Jan 12, 2026
Record Details
This FDA Inspection record concerns ZIIP INC, with an inspection on January 12, 2026, issued by the San Francisco District Office, covering medical devices & rad health.
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ID · aa315ce5-5ea6-4c31-acc8-43d8f3d750c8
Inspection Facts
- Inspection number
- 1298958
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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