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FDA establishment 3015376495, Boston, Massachusetts, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 1
Last inspection ended: Oct 27, 2023
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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.
21 CFR 812.140(a)(3). Investigator's subject records inadequate Records of each subject's case history are not all accurate and complete.
21 CFR 812.43(d). Monitors not qualified Monitors that are qualified by training and experience were not chosen to monitor the investigational study.
21 CFR 812.43(c)(4)(i). No investigation agreement statement of commitment A signed agreement that includes a statement of the investigator's commitment to conduct an investigation in accordance with the investigational plan, conditions of approval imposed by the reviewing IRB and conditions of approval imposed by the FDA was not obtained from each participating investigator.
21 CFR 812.43(c)(4)(iii). No informed consent statement in investigator agreement A signed agreement that includes a statement of the investigator's commitment to ensure that the requirements for obtaining informed consent are met was not obtained from each participating investigator.
21 CFR 812.25(e). Sponsor's lack of written monitoring procedures There are no written procedures for monitoring an investigational device study.
21 CFR 812.140(b)(2). Sponsor device shipment records inadequate Records of shipment of an investigational device that include the name and address of the consignee, type and quantity of device, date of shipment and batch number or code mark reports are not all complete.
21 CFR 812.43(c)(4)(ii). No supervision commitment in investigator agreement A signed agreement that includes a statement of the investigator's commitment to supervise all testing of the device involving human subjects was not obtained from each participating investigator.
21 CFR 812.40. Sponsors' general responsibilities For an investigational study, proper monitoring was not ensured.
21 CFR 812.5(a). Label does not contain required information The label for an investigational device does not include the name and place of business of manufacturer, packer, or distributor, the quantity of contents and the statement "CAUTION -- Investigational device. Limited by Federal (or United States) law to investigational use.".
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. 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 and warning letters
Boston, Massachusetts, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.