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.
ISO 13485:2016 Clause 7.4.1. Supplier monitoring and re-evaluation not planned The monitoring and re-evaluation of suppliers was not planned.
21 CFR 806.20(a). Records not kept There is no record maintained of a correction or removal action that was not required to be reported to FDA.
ISO 13485:2016 Clause 4.1.1. QMS not documented and maintained adequately The quality management system effectiveness was not maintained in accordance with applicable regulatory requirements.
ISO 13485:2016 Clause 4.1.6. QMS software not validated prior to use or changes Quality management system software was not validated prior to its initial use.
ISO 13485:2016 Clause 8.5.2. Corrective action not taken Corrective action was not adequately taken to eliminate the cause of nonconformities in order to prevent recurrence.
ISO 13485:2016 Clause 7.4.3. Purchased product verification activities not established or implemented The inspection or other activities necessary for ensuring that purchased product meets specified purchasing requirements were not adequately established and implemented.
ISO 13485:2016 Clause 7.1. Records of risk management activities in product realization not maintained Records of risk management activities in product realization were not maintained.
ISO 13485:2016 Clause 8.2.2. Complaint handling records not maintained Complaint handling records were not adequately maintained.
7382.850, Inspection of Medical Device Manufacturers
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
Wixom, Michigan, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.