Atlas

FDA-Inspected Site

SUMMA THERAPEUTICS, LLC

1 FDA inspection is on record for SUMMA THERAPEUTICS, LLC in Allston, United States.

483· Form 483 issued

Allston, United States · Last updated July 12, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-02-26.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
5 Feb 2026 – 26 Feb 2026Medical Devices & Rad Health483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

26 Feb 2026
21 CFR 806.10(a)(2)

Report of violation of the Act (see 803.52(e)(9))

Cited by Thomas Siebertz, Sara M Onyango

26 Feb 2026
ISO 13485:2016 Clause 4.1.5

Control over outsourced processes not proportionate to risk

Cited by Thomas Siebertz, Sara M Onyango

26 Feb 2026
ISO 13485:2016 Clause 7.3.7

Design and development validation not performed as planned

Cited by Thomas Siebertz, Sara M Onyango

26 Feb 2026
ISO 13485:2016 Clause 7.3.8

Design and development transfer procedures lack required elements

Cited by Thomas Siebertz, Sara M Onyango

26 Feb 2026
ISO 13485:2016 Clause 7.5.6

Procedures for validation of processes not documented

Cited by Thomas Siebertz, Sara M Onyango

Investigators

FDA investigators tied to this site in the record.

Thomas Siebertz1 insp.
Sara M Onyango1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 806.10(a)(2)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.1.5Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.3.7Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.3.8Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.6Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.7Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind SUMMA THERAPEUTICS, LLC's 1 Form 483

Recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat