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.
21 CFR 801.20(a). Label to bear a unique device identifier The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been established to control product that does not conform to specified requirements.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.40. Procedures not adequately established or maintained Document control procedures have not been adequately established.
21 CFR 820.20(e). Quality System Procedures Quality system procedures and instructions have not been established.
21 CFR 820.30(a). Design control - no procedures Procedures for design control have not been established.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis was not performed.
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 established.
21 CFR 830.300(a). Devices subject to device identification GUDID data submission requirements. The information required by the Global Unique Device Identification Database for each medical device version or model required to bear a unique device identifier (UDI) was not provided.
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
Detroit, Michigan, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.