FDA Inspection
Cyberlogic, Inc.Cyberlogic, Inc. – FDA Inspection, Mar 25, 2019
Record Details
This FDA Inspection record concerns Cyberlogic, Inc., with an inspection on March 25, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f5947025-fb4f-43a2-95b0-54da02e4f664
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1083804
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.30(j)Design history file
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.80(e)Documentation
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Other FDA inspections of Cyberlogic, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2026 | Not classified | New York District Office | |
| May 24, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cyberlogic, Inc.
- FDA Inspection 1317594 - 2026-04-07
- FDA Inspection 1214732 - 2023-05-24
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