FDA Inspection
Currie Medical Inc.Currie Medical Inc. – FDA Inspection, May 15, 2026
Record Details
This FDA Inspection record concerns Currie Medical Inc., with an inspection on May 15, 2026, issued by the Baltimore District Office, covering medical devices & rad health.
- Person
View Company Profile
ID · ca44ed8d-aabe-4a20-b348-215b10a7e612
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1317884
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.5.6Computer software used in production and service provision not validated
- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented
- ISO 13485:2016 Clause 7.6Procedures for monitoring and measuring equipment requirements not documented
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