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 3009236726, Salem, Massachusetts, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record .
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 820.150(a). Storage procedures to prevent mix-ups Procedures for controlling the storage of product in storage areas and stock rooms were not established and defined and implemented to prevent mix-ups, damage, other adverse effects.
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 adequately established.
21 CFR 820.20(d). Quality plan A quality plan has not been adequately established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.30(g). Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities.
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. 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
Salem, Massachusetts, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.