| Jul 23, 2025 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | None posted | No Action Indicated (NAI) |
| Mar 7, 2023 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 2 cited references- 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 820.50. 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.
| Voluntary Action Indicated (VAI) |
| Nov 18, 2021 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 4 cited references- 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 820.40(b). Document change records, maintained. Records of changes to documents were not adequately maintained.
- 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.
- 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.
| No Action Indicated (NAI) |
| Feb 20, 2018 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 5 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 820.30(j). Design history file The design history file does not demonstrate that the design was developed following the approved design plan.
- 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 820.30(f). Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.
- 21 CFR 820.40(b). Document change records, maintained. Records of changes to documents were not maintained.
| No Action Indicated (NAI) |
| Nov 9, 2016 | Devices · Compliance: DevicesDevices · Postmarket Assurance: 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 according to established procedures.
- 21 CFR 820.50(a). Evaluation of suppliers, contractors, etc., requirements Requirements that must be met by suppliers have not been established.
- 21 CFR 820.30(g). Design validation - simulated testing The design was not validated under actual or simulated use conditions.
- 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 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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
- 21 CFR 820.22. Quality audits - auditor independence Individuals who conduct quality audits have direct responsibility for the matters being audited.
- 21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been established.
- 21 CFR 820.250(a). Statistical techniques - Lack of or inadequate procedures Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been adequately established.
- 21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is inadequate.
| Voluntary Action Indicated (VAI) |
| Jul 31, 2014 | Devices · Compliance: Devices | 11 cited references- 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 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
- 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 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been adequately established.
- 21 CFR 820.30(j). Design history file The design history file was not established.
- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
- 21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been adequately established.
- 21 CFR 820.50(a). Evaluation of suppliers, contractors, etc., requirements Requirements that must be met by suppliers have not been adequately established.
- 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.
- 21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits 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.
| Voluntary Action Indicated (VAI) |
| Aug 26, 2011 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 10 cited references- 21 CFR 820.184. DHR - not or inadequately maintained A device history record has not been adequately maintained.
- 21 CFR 820.180. Availability Required records are not stored to minimize deterioration and prevent loss.
- 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(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
- 21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been adequately established.
- 21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
- 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 803.50(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 820.181. DMR - not or inadequately maintained A device master record has not been adequately maintained.
- 21 CFR 820.25(b). Training records Personnel training is not documented.
| Voluntary Action Indicated (VAI) |
| Jul 21, 2010 | Devices · Compliance: Devices | 23 cited references- 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 820.20(b). Lack of or inadequate organizational structure The organization structure is not adequate to assure that quality system requirements are fully met.
- 21 CFR 820.20(b)(3). Management representative No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.
- 21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures were not followed for the control of products that do not conform to specifications.
- 21 CFR 820.200(d)(6). Test and inspection data Service reports do not include applicable test and/or inspection data.
- 21 CFR 820.75(b)(2). Documentation of validated process performance There is no documentation of the major equipment used for a validated process.
- 21 CFR 820.40. Lack of procedures, or not maintained Document control procedures were not implemented.
- 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 820.70(i). Documentation of software validation Software validation activities for computers or automated data processing systems used as part of production have not been fully documented.
- 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 820.80(b). Incoming inspection, testing, verification Incoming product was not adequately inspected or tested to verify conformance to specifications.
- 21 CFR 820.75(c). Documentation - review in response to changes or deviations There is no documentation of the revalidation of a process conducted in response to changes or process deviations.
- 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 were not implemented.
- 21 CFR 820.25(b). Training records Employee training is not fully documented.
- 21 CFR 820.70(c). Environmental control system-documentation/review inspection Inspections of environmental control system were not reviewed.
- 21 CFR 820.100(a)(4). CAPA verification/validation of corrective/preventive action Corrective and preventive actions have not been verified or validated to ensure that the action is effective and does not adversely affect the finished device.
- 21 CFR 820.181(c). DMR QA procedures and specifications The device master record does not include or refer to the location of all quality assurance procedures and specifications.
- 21 CFR 820.30(a). Design control - no procedures Procedures to control the design process of the device were not defined, documented, complete, and implemented.
- 21 CFR 820.75(a). Documentation Process validation activities and results have not been fully documented.
- 21 CFR 820.70(a). Production processes Production processes were not complete and controlled to ensure that a device conforms to its specifications.
- 21 CFR 820.170(a). Lack of or inadequate instructions Installation, inspection, and test procedures have not been established, documented, and implemented such that the device will perform as intended after installation.
- 21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Appropriate procedures have not been defined for controlling environmental conditions.
- 21 CFR 820.184. DHR content The device history record does not demonstrate the device is manufactured in accordance with the device master record.
| Voluntary Action Indicated (VAI) |
| Nov 5, 2009 | Devices · Compliance: Devices | 3 cited references- 21 CFR 820.200(b). Analyzing service report Service reports were not analyzed following appropriate statistical methods.
- 21 CFR 820.200(a). Servicing - Lack of or inadequate procedures Servicing procedures have not been established.
- 21 CFR 820.22. Quality audits - auditor independence Individuals who conduct quality audits have direct responsibility for the matters being audited.
| Voluntary Action Indicated (VAI) |
| Sep 15, 2009 | Devices · Compliance: Devices | None posted | Voluntary Action Indicated (VAI) |
Uxbridge, Massachusetts, United States. Part of