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FDA establishment 3007472402, Palm Bch Gdns, Florida, United States. Part of Excel Medical Electronics, LLC's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 0
Last inspection ended: Dec 19, 2025
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 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
21 CFR 820.30(g). Design validation - Risk analysis Results of the design risk analysis were not adequately documented.
21 CFR 820.30(g). Design validation - software validation not performed Validation of device software is inadequate.
21 CFR 820.170(b). Installer records The person installing the device did not adequately document the inspection and test results to demonstrate proper installation.
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.
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
Palm Bch Gdns, Florida, United States. Part of