FDA Inspection
Vitalcor, Inc.Vitalcor, Inc. – FDA Inspection, Aug 14, 2026
Record Details
This FDA Inspection record concerns Vitalcor, Inc., with an inspection on August 14, 2026, issued by the Chicago District Office, covering medical devices & rad health.
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ID · e03e98b6-8c9e-4c1e-bcbb-b2be4d600315
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1330954
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 4.2.4Lack of document control
- ISO 13485:2016 Clause 5.6.1Management review procedures not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Vitalcor, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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