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FDA establishment 3027395815, Allston, Massachusetts, United States. Part of Summa Therapeutics's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 1
Official action indicated: 1
Last inspection ended: Feb 26, 2026
Warning letters: 0
Recalls since 2016: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
02018Inspections0
020192019Inspections0vs 2018+0
02020Inspections0vs 2019+0
020212021Inspections0vs 2020+0
02022Inspections0vs 2021+0
020232023Inspections0vs 2022+0
02024Inspections0vs 2023+0
020252025Inspections0vs 2024+0
12026Inspections1vs 2025+1
020272027 to dateInspections0
Most Cited at This Site
Inspections citing each reference
ISO 13485:2016 Clause 8.2.1: Feedback process procedures not documented1
ISO 13485:2016 Clause 7.5.6: Procedures for validation of processes not documented1
ISO 13485:2016 Clause 8.2.1. Feedback process procedures not documented Procedures for the feedback process have not been documented.
ISO 13485:2016 Clause 7.5.6. Procedures for validation of processes not documented Procedures for validation of processes were not adequately documented.
21 CFR 806.10(a)(2). Report of violation of the Act (see 803.52(e)(9)) A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.
ISO 13485:2016 Clause 7.3.7. Design and development validation not performed as planned Design and development validation was not adequately performed in accordance with planned and documented arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.
ISO 13485:2016 Clause 8.5.2. Corrective action procedures not documented Corrective action procedures defining the requirements for reviewing the effectiveness of corrective action taken have not been adequately documented.
ISO 13485:2016 Clause 7.3.8. Design and development transfer procedures lack required elements Procedures for transfer of design and development outputs to manufacturing do not adequately ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications.
ISO 13485:2016 Clause 7.5.7. Sterilization and sterile barrier system validation procedures not documented Procedures for the validation of processes for sterilization were not adequately documented.
ISO 13485:2016 Clause 4.1.5. Control over outsourced processes not proportionate to risk Controls over outsourced processes that affect product conformity to requirements are not proportionate to the risk involved.
Official Action Indicated (OAI)
Recalls
1 drug, device and biologic recalls since 2016, newest first; 0 Class I
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Allston, Massachusetts, United States. Part of