Sairem Corp. – FDA Inspection, May 16, 2025

Record Details

This FDA Inspection record concerns Sairem Corp., with an inspection on May 16, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Sairem Corp.
Inspection Date: May 16, 2025
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
People: Fouad Attioui (Issuing Officer)
Gregory M. Bessette (Issuing Officer)

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ID · d51050ef-2336-426f-96e9-fb5b8eaa461a

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1270563
FDA center: Medical Devices & Rad Health
Project area: Radiation Control and Health Safety Act (RCHSA) Authority
Outcome: Form 483 issued

FDA Citations

21 CFR 1010.2(c)Certification not based on adequate test/testing program
21 CFR 1030.10(c)(2)(vi)Means to monitor interlocks
21 CFR 1030.10(c)(3)(i)tests--errors and uncertainties accounted for

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FDA Inspection

Sairem Corp.May 16, 2025