FDA Inspection 1306234 — SUMMA THERAPEUTICS, LLC
The FDA completed an inspection of SUMMA THERAPEUTICS, LLC on February 26, 2026 in Allston, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 26, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Allston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23025 | ISO 13485:2016 Clause 4.1.5 | Control over outsourced processes not proportionate to risk |
| 23119 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not performed as planned |
| 23128 | ISO 13485:2016 Clause 7.3.8 | Design and development transfer procedures lack required elements |
| 23169 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes not documented |
| 23175 | ISO 13485:2016 Clause 7.5.7 | Sterilization and sterile barrier system validation procedures not documented |
| 23212 | ISO 13485:2016 Clause 8.2.1 | Feedback process procedures not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |