| May 5, 2023 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 4 cited references- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action 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.
- 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 803.17(a)(1). Lack of System for Event Evaluations The written MDR Procedure does not include an internal system which provides for timely and effective identification of events that may be subject to medical device reporting requirements.
| Voluntary Action Indicated (VAI) |
| Nov 3, 2022 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 2 cited references- 21 CFR 806.10(a)(1). Report of risk to health A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.
- 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) |
| Sep 9, 2021 | Devices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Oct 17, 2019 | Devices · Compliance: Devices | 2 cited references- 21 CFR 820.30(c). Design input - documentation Design input requirements were not adequately documented.
- 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) |
| Aug 6, 2019 | Devices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Jun 21, 2018 | Devices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Jun 30, 2017 | Devices · Compliance: DevicesDevices · 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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
| Voluntary Action Indicated (VAI) |
| Jun 7, 2017 | Devices · Compliance: Devices | None posted | Voluntary Action Indicated (VAI) |
| Oct 26, 2015 | Devices · Compliance: Devices | 4 cited references- 21 CFR 806.10(a)(1). Report of risk to health A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.
- 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.
- 21 CFR 820.40. Procedures not adequately established or maintained Document control procedures have not been adequately established .
| Voluntary Action Indicated (VAI) |
| Dec 19, 2013 | Devices · Bioresearch Monitoring | None posted | Voluntary Action Indicated (VAI) |
| Apr 3, 2013 | Devices · Compliance: Devices | 4 cited references- 21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change 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 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 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
| Official Action Indicated (OAI) |
| May 9, 2012 | Drugs · Drug Quality AssuranceDevices · Compliance: Devices | None posted | Official Action Indicated (OAI) |
| Jan 21, 2011 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 5 cited references- 21 CFR 820.30(c). Design input - documentation Design input requirements were not adequately documented.
- 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 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 820.30(g). Design validation - production units The design was not validated using initial production units, lots or batches or their equivalents.
- 21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
| Voluntary Action Indicated (VAI) |
| Jul 20, 2010 | Drugs · Postmarket Surv. and EpidemiologyDrugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Mar 24, 2009 | Devices · Postmarket Assurance: Devices | None posted | No Action Indicated (NAI) |
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