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

FDA Inspection 1306234 for SUMMA THERAPEUTICS, LLC on February 26, 2026. Classification: N/A.

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Record Summary

FDA Inspection 1306234 for SUMMA THERAPEUTICS, LLC on February 26, 2026. Classification: N/A.

Violation Codes

21 CFR 806.10(a)(2)

ISO 13485:2016 Clause 4.1.5

ISO 13485:2016 Clause 7.3.7

ISO 13485:2016 Clause 7.3.8

ISO 13485:2016 Clause 7.5.6

ISO 13485:2016 Clause 7.5.7

ISO 13485:2016 Clause 8.2.1

ISO 13485:2016 Clause 8.5.2

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Record Information

Company

SUMMA THERAPEUTICS, LLC

Inspection Date

February 26, 2026

Product Type

Medical Devices & Rad Health

Office

New England District Office

ID: 86384b92-8bd6-4956-a13a-60c0a8b21692

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