WEERO CO LTD – FDA Inspection, Sep 5, 2024

Record Details

This FDA Inspection record concerns WEERO CO LTD, with an inspection on September 5, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: WEERO CO LTD
Inspection Date: September 5, 2024
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Marlo-Ian M. Alintanahin (Issuing Officer)

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ID · c60dcb84-1080-42e9-a90a-2ed850f1852b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1248487
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.100(b)Documentation
21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements

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FDA Inspection

WEERO CO LTDSeptember 5, 2024