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21 CFR 803.50(a)(1). Report of Death or Serious Injury An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately 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 adequately established.
21 CFR 820.70(e). Contamination control, Lack of or inadequate procedures Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
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 validated according to established procedures.
Voluntary Action Indicated (VAI)
Nov 8, 2023
Devices · Compliance: Devices
7 cited references
21 CFR 820.200(d). Service reports Service reports do not include the required information.
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(e). Contamination control, Lack of or inadequate procedures Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality 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 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.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs 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 adequately established.
21 CFR 806.10(b). Time to report - 10 days A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the correction or removal.
Voluntary Action Indicated (VAI)
Sep 10, 2013
Devices · Postmarket Assurance: Devices
2 cited references
21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
21 CFR 820.30(f). Design verification - documentation The design verification results, including identification of the design, method(s), the date, and the individual(s) performing the verification, were not adequately documented in the design history file.
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
Earth City, Missouri, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.