FDA Inspection
SUMMA THERAPEUTICS, LLCSUMMA THERAPEUTICS, LLC – FDA Inspection, Feb 26, 2026
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
View Company Profile
ID · 526f2db7-4579-4625-86d9-312d0a36047e
Inspection Facts
- Inspection number
- 1306234
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
8- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- ISO 13485:2016 Clause 4.1.5Control over outsourced processes not proportionate to risk
- ISO 13485:2016 Clause 7.3.7Design and development validation not performed as planned
- ISO 13485:2016 Clause 7.3.8Design and development transfer procedures lack required elements
- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented
- ISO 13485:2016 Clause 7.5.7Sterilization and sterile barrier system validation procedures not documented
- ISO 13485:2016 Clause 8.2.1Feedback process procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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