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FDA establishment 3004753838, San Diego, California, United States. Part of Dexcom's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, its recalls since 2016, and the shipments FDA refused at the border.
Inspections: 11
Official action indicated: 3
Last inspection ended: Nov 7, 2024
Warning letters: 1
Recalls since 2016: 11
Import refusals since 2024: 4
Import refusals 2014 to 2023: 2, first Nov 28, 2023
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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.30(d). Design output - Lack of or inadequate procedures Procedures for design output have not been adequately established.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is inadequate and is incomplete.
21 CFR 820.75(b). Lack/Inad procedure-Monitoring/Control of Validated Proces Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
21 CFR 820.30(c). Design input - Lack of or inadequate procedures Procedures for design input have not been adequately established.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Voluntary Action Indicated (VAI)
Feb 16, 2018
Devices · Bioresearch Monitoring
1 cited reference
21 CFR 812.40. Sponsors' general responsibilities For an investigational study, proper monitoring was not ensured.
Voluntary Action Indicated (VAI)
Mar 29, 2016
Devices · Project Evaluation: Devices
1 cited reference
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been implemented.
21 CFR 803.17(a)(1). Lack of System for Event Evaluations The written MDR Procedure does not include an internal system which provides for the timely and effective identification and evaluation of events that may be subject to medical device reporting requirements.
21 CFR 803.50(a)(1). Report of Death or Serious Injury An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
21 CFR 803.50(a)(2). Individual Report of Malfunction An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
21 CFR 803.17(b). Information used for annual reports The written MDR procedure does not include documentation and recordkeeping requirements for any information that was evaluated for the purpose of preparing the submission of semiannual reports.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed and maintained.
21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Appropriate procedures have not been followed for controlling environmental conditions.
21 CFR 820.70(c). Environmental control system periodic inspections Environmental control systems have not been inspected periodically to verify that the system, including necessary equipment, is adequate and functioning properly.
21 CFR 820.30(g). Design validation - software validation not performed Validation of device software is incomplete.
21 CFR 820.30(f). Design verification - Lack of or inadequate procedures Design verification did not confirm that the design output meets the design input requirements.
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
San Diego, California, United States. Part of