| Jul 27, 2022 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Oct 16, 2017 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 8 cited references- 21 CFR 820.130. Packaging Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.
- 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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
- 21 CFR 820.75(b). Lack/Inad procedure-Monitoring/Control of Validated Proces Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
- 21 CFR 820.70(i). Software validation for automated processes Software used as part of the quality system has not been adequately validated for its intended use according to an established protocol.
- 21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been implemented.
- 21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated have not been adequately established.
- 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.
| Voluntary Action Indicated (VAI) |
| Nov 20, 2015 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 10 cited references- 21 CFR 820.72(b). Remedial action When test/measurement equipment was found to not meet accuracy and precision limits, inadequate action was taken to evaluate whether there was any adverse effect on the device's quality .
- 21 CFR 820.250(b). Sampling plans Sampling plans are not based on valid statistical rationale .
- 21 CFR 820.30(d). Design output - documentation Design output was not documented before release.
- 21 CFR 803.17(a)(2). Lack of System for Determining MDR Events The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting.
- 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 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established.
- 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.
- 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.
- 21 CFR 820.130. Packaging Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.
- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
| Official Action Indicated (OAI) |
| May 28, 2014 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 12 cited references- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
- 21 CFR 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been established.
- 21 CFR 820.30(j). Design history file The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
- 21 CFR 820.130. Packaging Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.
- 21 CFR 820.20(e). Quality System Procedures Quality system procedures and instructions have not been established.
- 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 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 820.90(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 820.198(e). Records of complaint investigation Records of complaint investigations do not include required information.
- 21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated 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 820.250(b). Sampling plans Sampling plans are not based on valid statistical rationale.
| Official Action Indicated (OAI) |
| Feb 7, 2014 | Devices · Bioresearch Monitoring | 2 cited references- 21 CFR 50.25(a)(2). Reasonably foreseeable risks or discomforts The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject.
- 21 CFR 812.46(a). Sponsor securing investigator compliance An investigator was not complying with the signed agreement and investigational plan and compliance of the investigator was not promptly secured.
| Voluntary Action Indicated (VAI) |
| Aug 19, 2013 | Devices · Compliance: Devices | None posted | Official Action Indicated (OAI) |
| Jun 20, 2013 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 10 cited references- 21 CFR 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been established.
- 21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
- 21 CFR 820.75(b). Lack/Inad procedure-Monitoring/Control of Validated Proces Procedures for monitoring and control of process parameters for a validated process 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 adequately validated according to established procedures.
- 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(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 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
- 21 CFR 820.30(d). Design output - Lack of or inadequate procedures Procedures for design output have not been adequately established.
- 21 CFR 820.130. Packaging Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.
- 21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained have not been adequately established.
| Official Action Indicated (OAI) |
| May 21, 2012 | Devices · Compliance: Devices | 5 cited references- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
- 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 820.181. DMR - not or inadequately maintained A device master record has not been maintained.
- 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 820.75(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.
| Official Action Indicated (OAI) |
| Jul 22, 2011 | Devices · Compliance: Devices | 10 cited references- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
- 21 CFR 820.80(c). Lack of or inadequate In-process acceptance procedures Procedures for the acceptance of in-process product have not been 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.
- 21 CFR 820.30(d). Design output - Lack of or inadequate procedures Procedures for design output have not been established.
- 21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been 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.
- 21 CFR 820.30(c). Design input - Lack of or inadequate procedures Procedures for design input have not been established.
- 21 CFR 820.72(a). Equipment suitability & capability Certain inspection, measuring, and test equipment is not suitable for its intended purposes.
- 21 CFR 820.20(a). Management ensuring quality policy is understood Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization.
- 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.
| Voluntary Action Indicated (VAI) |
| Mar 19, 2009 | Devices · Project Evaluation: DevicesDevices · Compliance: Devices | None posted | No Action Indicated (NAI) |
Warsaw, Indiana, United States. Part of