Biopoly Llc – FDA Inspection, Apr 30, 2026

Record Details

This FDA Inspection record concerns Biopoly Llc, with an inspection on April 30, 2026, issued by the Detroit District Office, covering medical devices & rad health.

Company: Biopoly Llc
Inspection Date: April 30, 2026
Product Type: Medical Devices & Rad Health
Office: Detroit District Office
Person: Suyang Qin (FDA Associated Person)

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ID · bb898ece-a654-4d41-9624-e4de53fafcab

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1315342
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued, view the record

FDA Citations

ISO 13485:2016 Clause 7.3.3Design and development inputs do not include all requirements
ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
ISO 13485:2016 Clause 8.4Procedures for analysis of data not documented
ISO 13485:2016 Clause 8.5.2Corrective action not taken

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FDA Inspection

Biopoly LlcApril 30, 2026