WISE PLASTICS TECHNOLOGIES INC – FDA Inspection, May 19, 2023

Record Details

This FDA Inspection record concerns WISE PLASTICS TECHNOLOGIES INC, with an inspection on May 19, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company: WISE PLASTICS TECHNOLOGIES INC
Inspection Date: May 19, 2023
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Jesse A. Vazquez (FDA Associated Person)

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ID · 3caf5fa9-911b-45dd-85e8-c05cfd5edf7b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1205766
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.20(d)Quality plan
21 CFR 820.70(i)Documentation of software validation

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FDA Inspection

WISE PLASTICS TECHNOLOGIES INCMay 19, 2023