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 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been adequately established.
21 CFR 820.120(d). Records, DHR {see also 820.184(e)} Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.
21 CFR 820.180(b). Retention period Required records are not retained for the design and expected life of the device and at least 2 years from the date of release of the device for commercial distribution.
21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been adequately established.
21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
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
Suzhou, China. Every inspection FDA has posted for the site, with its outcome and cited regulations.