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FDA establishment 2025773, San Diego, California, United States. Part of Apex Medical Technologies's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 0
Last inspection ended: Jan 15, 2026
Warning letters: 0
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.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action 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)
Sep 28, 2023
Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices; Devices · Radiation Control and Health Safety Act
21 CFR 820.70(f). Buildings Buildings are not of suitable design to perform necessary operations.
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 820.40(a). Not approved or obsolete document retrieval Documents that were obsolete were observed at a location where they are being used.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been adequately established.
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
San Diego, California, United States. Part of