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 3002808402, Sommacampagna, Italy. Part of Tecres S.p.A.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 820.30(g). Design validation - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
21 CFR 803.17(a)(3). Lack of System for Timely Submission of Reports The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to FDA.
21 CFR 803.50(a)(2). Individual Report of Malfunction An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Official Action Indicated (OAI)
Jan 26, 2012
Devices · Compliance: Devices
3 cited references
21 CFR 820.80(c). Lack of or inadequate In-process acceptance procedures Procedures for the control of in-process product have not been adequately established.
21 CFR 820.30(f). Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
Sommacampagna, Italy. Part of