FDA establishment 3004987960, Charles Town, West Virginia, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 820.30(g). Design validation - software validation not performed Validation of device software was not performed.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis was not performed.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been documented.
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 reviewed, evaluated and investigated where necessary.
21 CFR 820.181(a). DMR device specifications The device master record does not include or refer to the location of device software specifications.
21 CFR 820.20(b). Lack of or inadequate organizational structure The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
Voluntary Action Indicated (VAI)
Aug 22, 2018
Devices · Compliance: Devices
5 cited references
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been established.
21 CFR 820.30(a). Design control - no procedures Procedures for design control have not been established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been established to control product that does not conform to specified requirements.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately 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 820.198(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 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820.
21 CFR 820.198(e). Maintained Records of complaint investigations are not maintained by the formally designated unit.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been established.
21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been adequately established.
21 CFR 820.50. 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 820.90(b)(2). Product rework documentation, DHR {see also 820.184} Rework and reevaluation activities have not been documented in the device history record.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
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.
Official Action Indicated (OAI)
Aug 17, 2009
Devices · Compliance: Devices
4 cited references
21 CFR 820.181(b). DMR production process specifications The device master record does not include or refer to the location of production and process specifications.
21 CFR 820.80(d)(3). No release signature Finished devices were released for distribution without signature of the individual designated to authorize such release.
21 CFR 820.198(a). Complete files maintained Complete complaint files are not maintained.
21 CFR 820.198(a). General Complaint handling procedures for receiving, reviewing, and evaluating complaints have not been established, defined, and documented.
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Charles Town, West Virginia, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.