FDA Inspection 1221741 - APS Materials Inc. Ireland - November 03, 2023

Record Details

This FDA Inspection record concerns APS Materials Inc. Ireland, with an inspection on November 3, 2023, issued by the Office of Inspections and Investigations.

Company: APS Materials Inc. Ireland
Inspection Date: November 3, 2023
Office: Office of Inspections and Investigations
Person: John A. Sciacchitano (Company Rep)

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ID · 2e3d352b-eccc-4e1e-8617-c7198d777570

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1221741
FDA center: Medical Devices & Rad Health
Outcome: Form 483 issued

FDA Citations

21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

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FDA Inspection

APS Materials Inc. IrelandNovember 3, 2023