FDA Inspection
iCE Neurosystems, Inc.iCE Neurosystems, Inc. – FDA Inspection, Nov 6, 2024
Record Details
This FDA Inspection record concerns iCE Neurosystems, Inc., with an inspection on November 6, 2024, issued by the Baltimore District Office, covering medical devices & rad health.
- Company
- iCE Neurosystems, Inc.
- Inspection Date
- November 6, 2024
- Product Type
- Medical Devices & Rad Health
- Person
View Company Profile
ID · de493bd3-8e63-49cf-9142-dfed32bd3115
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1254190
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
4- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.