Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
FDA establishment 3032814119, Miami, Florida, United States. Part of InspireMD'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: 0
Last inspection ended: Jun 18, 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 8.2.2: Complaint handling records not maintained1
ISO 13485:2016 Clause 5.6.2: Input to management review is incomplete1
ISO 13485:2016 Clause 8.5.2: Corrective action not taken1
ISO 13485:2016 Clause 8.2.1: Information gathered in feedback process not used as input into risk management1
ISO 13485:2016 Clause 8.2.2. Complaint handling records not maintained Complaint handling records were not maintained.
ISO 13485:2016 Clause 5.6.2. Input to management review is incomplete Management review input does not adequately include information arising from feedback, complaint handling, reporting to regulatory authorities and recommendations for improvement.
ISO 13485:2016 Clause 8.5.2. Corrective action not taken Corrective action was not taken to eliminate the cause of nonconformities in order to prevent recurrence.
ISO 13485:2016 Clause 8.2.1. Information gathered in feedback process not used as input into risk management Information gathered in the feedback process does not serve as potential input into risk management for monitoring and maintaining product requirements as well as the product realization or improvement processes.
21 CFR 820.198(d). Evaluation, timeliness, identification Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated by a designated individual.
Voluntary Action Indicated (VAI)
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
Miami, Florida, United States. Part of