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 820.40(a). Document review, approval documentation The documentation of approval of documents does not include.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been maintained.
21 CFR 807.25(g). Device listing information not submitted The owner or operator did not submit the required device listing information in the electronic registration and listing system and did not request a waiver.
21 CFR 820.70(i). Software validation for automated processes Software used as part of the quality system has not been validated for its intended use according to an established protocol.
21 CFR 820.40. Lack of procedures, or not maintained Document control procedures have not been established.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been established.
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 820.198(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 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 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed.
Voluntary Action Indicated (VAI)
Nov 2, 2015
Devices · Compliance: Devices
3 cited references
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed, maintained, and implemented.
21 CFR 820.30(a). Design control - no procedures Procedures for design control have not been established.
21 CFR 820.198(a). Complaints Complaint files are not maintained.
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
New York, New York, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.