# SUMMA THERAPEUTICS, LLC – FDA 483, Feb 26, 2026

Source: https://www.keypedia.com/records/483/summa-therapeutics-llc/77866314-88bb-4f65-96d3-a2a1a06068f7

> FDA 483 for SUMMA THERAPEUTICS, LLC on February 26, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SUMMA THERAPEUTICS, LLC
- Inspection Date: 2026-02-26
- Product Type: device
- Office Name: New England District Office
- Summary: SUMMA THERAPEUTICS, LLC, a medical device manufacturer in Allston, MA, was cited with eight observations on a Form 483 following an FDA inspection. The inspection revealed significant deficiencies in process validation for sterilization and sterile barrier processes, inadequate design validation, and poor control over outsourced manufacturing. Additionally, the firm failed to report a device recall to the FDA, indicating systemic issues with documented procedures and adherence to quality system requirements.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)
- [Thomas Siebertz](https://www.keypedia.com/people/thomas-siebertz/a2547520-c652-4303-822c-e32648dc9b01)

Company: https://www.keypedia.com/companies/summa-therapeutics-llc/f24c892b-5815-4cc9-9004-20a31bf86583

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144