FDA Inspection 1306234 - SUMMA THERAPEUTICS, LLC - February 26, 2026

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Record Details

This FDA Inspection record concerns SUMMA THERAPEUTICS, LLC, with an inspection on February 26, 2026, issued by the New England District Office, covering medical devices & rad health.

Company: SUMMA THERAPEUTICS, LLC
Inspection Date: February 26, 2026
Product Type: Medical Devices & Rad Health
Office: New England District Office

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ID · 526f2db7-4579-4625-86d9-312d0a36047e

Violation Codes8

21 CFR 806.10(a)(2)ISO 13485:2016 Clause 4.1.5ISO 13485:2016 Clause 7.3.7ISO 13485:2016 Clause 7.3.8ISO 13485:2016 Clause 7.5.6ISO 13485:2016 Clause 7.5.7ISO 13485:2016 Clause 8.2.1ISO 13485:2016 Clause 8.5.2

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