| Aug 19, 2025 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 18 cited references- 21 CFR 820.30(j). Design history file The design history file was not established.
- 21 CFR 820.50(a). Evaluation of suppliers, contractors, etc., requirements Requirements that must be met by contractors and consultants 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 801.20(a). Label to bear a unique device identifier The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
- 21 CFR 820.40. Procedures not adequately established or maintained Document control procedures 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 820.181. DMR - not or inadequately maintained A device master record has not been adequately maintained.
- 21 CFR 820.70(a). Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
- 21 CFR 803.17(a)(3). Lack of System for Timely Submission of Reports The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to FDA.
- 21 CFR 820.30(f). Design verification - Lack of or inadequate procedures Procedures for design verification 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 820.75(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 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis was not performed and is incomplete.
- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
- 21 CFR 820.70(g). Equipment design and installation Equipment used in the manufacturing process has not been appropriately designed, constructed and installed to facilitate maintenance, adjustment, cleaning, and use.
- 21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
- 21 CFR 820.70(f). Buildings Buildings are not of suitable design to perform necessary operations.
- 21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been adequately established.
| Official Action Indicated (OAI) |
| Feb 28, 2024 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 6 cited references- 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 820.50. 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 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
- 21 CFR 803.17(b)(1). Info evaluated to determine if event was reportable The written MDR procedure does not include documentation and recordkeeping requirements for all information that was evaluated to determine if an event was reportable.
- 21 CFR 820.90(b)(1). Procedures for product review,disposition lack of/inadequate Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been established.
- 21 CFR 820.80(c). Lack of or inadequate In-process acceptance procedures Procedures for the acceptance and control of in-process product have not been adequately established.
| Voluntary Action Indicated (VAI) |
| Jun 28, 2021 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 4 cited references- 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 820.20(c). Management review - defined interval, sufficient frequency Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system.
- 21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been documented.
- 21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
| No Action Indicated (NAI) |
| Jun 21, 2017 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 17 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 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been adequately established.
- 21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device and labeling to meet any of its specifications were not where necessary.
- 21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
- 21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been adequately established.
- 21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed and implemented.
- 21 CFR 820.30(a). Design control - no procedures Procedures for design control 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 820.70(g)(1). Maintenance schedule, Lack of or inadequate schedule Schedules for the adjustment, cleaning, and other maintenance of equipment have not been 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 820.40(a). Not approved or obsolete document retrieval Documents that were not approved were observed at a location where they could be and are being used.
- 21 CFR 820.50(a)(1). Evaluation and Selection, Suppliers, Contractors, etc. Potential suppliers were not evaluated and selected based on their ability to meet specified requirements.
- 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 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated have not been adequately established.
- 21 CFR 820.30(f). Design verification - documentation The design verification results, including method(s), were not documented in the design history file.
- 21 CFR 820.70(a). Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
- 21 CFR 820.70(g). Equipment Installation, Placement, Specified Requirements The equipment used in the manufacturing process does not meet specified requirements.
| Official Action Indicated (OAI) |
| Feb 8, 2017 | Devices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Aug 3, 2015 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 4 cited references- 21 CFR 820.80(b). Incoming acceptance records, documentation Acceptance or rejection of incoming product was not documented.
- 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 820.75(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 820.70(a). Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
| No Action Indicated (NAI) |
| Apr 18, 2013 | Devices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Oct 29, 2012 | Devices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Feb 28, 2011 | Devices · Compliance: Devices | 4 cited references- 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 820.75(a). Documentation Process validation activities and results have not been documented.
- 21 CFR 820.80(c). Lack of or inadequate In-process acceptance procedures Procedures for the acceptance of in-process product have not been adequately established.
- 21 CFR 820.70(g). Equipment Installation, Placement, Specified Requirements The appropriate design, construction, placement, and installation of manufacturing equipment have not been ensured.
| Official Action Indicated (OAI) |
| May 28, 2010 | Devices · Compliance: Devices | 10 cited references- 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 and approved according to established procedures.
- 21 CFR 820.80(c). Lack of or inadequate In-process acceptance procedures Acceptance procedures to ensure that specified requirements for in-process product are met were not implemented.
- 21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure that equipment is routinely calibrated were not established.
- 21 CFR 820.25(b). Training records Employee training is not fully documented.
- 21 CFR 820.184(a). DHR content - manufacturing dates The device history record does not include manufacturing dates.
- 21 CFR 820.100(a). Lack of or inadequate procedures The procedures for implementing corrective and preventive actions were not implemented.
- 21 CFR 820.184. DHR content The device history record does not demonstrate the device is manufactured in accordance with the device master record.
- 21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for acceptance or rejection of finished device production runs, lots, or batches were not documented.
- 21 CFR 820.72(a). Equipment control activity documentation Equipment calibrations have not been documented.
- 21 CFR 820.100(a)(2). Investigation Certain indicators of nonconformities are not investigated to determine the cause of the nonconformity.
| Official Action Indicated (OAI) |
| Feb 3, 2010 | Devices · Compliance: Devices | 4 cited references- 21 CFR 820.72(a). Equipment suitability & capability Certain measuring and test equipment is not suitable for its intended purposes or capable of producing valid results.
- 21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Appropriate procedures have not been followed for controlling environmental conditions.
- 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 and approved according to established procedures.
- 21 CFR 820.72(b)(2). Calibration documentation There is incomplete documentation of calibration dates, the individual performing each calibration, and the next calibration date for measurement and test equipment .
| Official Action Indicated (OAI) |
| Apr 3, 2009 | Devices · Compliance: Devices | 7 cited references- 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 and approved according to established procedures.
- 21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Appropriate procedures have not been defined, documented, and followed for controlling environmental conditions.
- 21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures were not complete and followed for the control of products that do not conform to specifications.
- 21 CFR 820.70(e). Contamination control, Lack of or inadequate procedures Procedures have not been followed to prevent contamination of equipment or product by certain substances.
- 21 CFR 820.70(d). Training temp work under special environmental conditions Maintenance and other personnel who are required to work temporarily under special environmental conditions are not appropriately trained or supervised by a trained individual.
- 21 CFR 820.72(b)(2). Calibration documentation There is incomplete documentation of calibration dates, the individual performing each calibration, and the next calibration date for measurement and test equipment .
- 21 CFR 820.72(a). Equipment suitability & capability Certain test equipment is not suitable for its intended purposes or capable of producing valid results.
| Voluntary Action Indicated (VAI) |
Phoenix, Arizona, United States. Part of