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 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 820.181. DMR - not or inadequately maintained A device master record has not been maintained.
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 820.40. Procedures not adequately established or maintained Document control procedures have not been adequately established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.70(i). Software validation for automated processes Software used as part of production and the quality system has not been validated for its intended use according to an established protocol.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been adequately established.
21 CFR 820.30(a). Design control - no procedures Procedures for design control have not been established.
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 820.70(a). Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed.
21 CFR 820.184. Lack of or inadequate DHR procedures Procedures for device history records have not been established.
21 CFR 820.120. Lack of or inadequate procedures for labeling Procedures to control labeling activities have not been established.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been adequately established.
21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated and inspected have not been established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
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
Phoenix, Arizona, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.