Agupunt USA Corp – FDA Inspection, Mar 25, 2026

Record Details

This FDA Inspection record concerns Agupunt USA Corp, with an inspection on March 25, 2026, issued by the Florida District Office, covering medical devices & rad health.

Company: Agupunt USA Corp
Inspection Date: March 25, 2026
Product Type: Medical Devices & Rad Health
Office: Florida District Office
Person: Ebony D. Sanon (Issuing Officer)

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ID · 0343619c-6db0-4ecb-91a2-15b93ddb5ea9

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1309232
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable

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FDA Inspection

Agupunt USA CorpMarch 25, 2026