Transcend Biologics, LLC – FDA Inspection, Aug 14, 2026

Record Details

This FDA Inspection record concerns Transcend Biologics, LLC, with an inspection on August 14, 2026, issued by the Dallas District Office, covering biologics.

Company: Transcend Biologics, LLC
Inspection Date: August 14, 2026
Product Type: Biologics
Office: Dallas District Office
People: Michelle Paxon (Issuing Officer)
Richard T. Riggie (Company Rep)

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ID · c8a4be29-f8eb-478f-965d-9448f8d96195

Inspection Facts

Inspection number: 1331790
FDA center: Biologics
Project area: Blood and Blood Products
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.6(d)Measuring equipment was not safeguarded from adjustments
ISO 13485:2016 Clause 8.2.2Relevant complaint information not exchanged with external party

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FDA Inspection

Transcend Biologics, LLCAugust 14, 2026