First Source Inc – FDA Inspection, Sep 19, 2023

Record Details

This FDA Inspection record concerns First Source Inc, with an inspection on September 19, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company: First Source Inc
Inspection Date: September 19, 2023
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Matthew D. Schnittker (Issuing Officer)

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ID · 9d5b597d-3f39-4991-af14-18caa913d5c1

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1218835
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 1002.30(a)(2)Basis for selecting methods, devices, procedures
21 CFR 1020.30(h)(2)(i)Tube housing assemblies (leakage technique factors)
21 CFR 1020.30(h)(2)(ii)Tube housing assemblies - cooling curves
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

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Other FDA inspections of First Source Inc

Date	Classification	Office	Project area
June 24, 2026	NAI	New York District Office	Postmarket Assurance: Devices
July 20, 2021	VAI	Center for Devices and Radiological Health	Compliance: Devices
May 25, 2018	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
June 10, 2016	VAI	Center for Devices and Radiological Health	Compliance: Devices