FDA establishment 3003064146, Hialeah, Florida, United States. Part of Rite-Dent Manufacturing's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 820.30(a). Design control - no procedures Procedures for design control have not been established.
21 CFR 820.72(a). Equipment control activity documentation Equipment calibrations, inspections, checks, and maintenance activities have not been documented.
21 CFR 820.80(a). Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been adequately established.
21 CFR 820.70(a). Production processes Production processes were not developed, conducted, controlled, and monitored to ensure that a device conforms to its specifications.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action 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.
21 CFR 820.184. Lack of or inadequate DHR procedures Procedures for device history records have not been established.
21 CFR 820.80(e). Documentation Acceptance activities were not documented and maintained as part of the device history record.
21 CFR 820.20(d). Quality plan A quality plan has not been adequately established.
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 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.
21 CFR 820.120. Lack of or inadequate procedures for labeling Procedures to control labeling activities have not been adequately established.
21 CFR 820.30(g). Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities.
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 820.30(f). Design verification - documentation The design verification results, including identification of the design, method(s), the date, and the individual(s) performing the verification, were not documented in the design history file.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis was not performed.
21 CFR 820.40. Lack of procedures, or not maintained Document control procedures have not been established and maintained.
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 820.72(a). Equipment control activity documentation Equipment calibrations and maintenance activities have not been documented.
21 CFR 820.250(b). Sampling plans Sampling plans are not based on valid statistical rationale.
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 820.30(a). Design control - no procedures Procedures for design control have not been established.
21 CFR 820.25(b). Training records Personnel training is not documented.
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 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
21 CFR 820.25(a). Personnel Personnel do not have the necessary training and experience to perform their jobs.
21 CFR 820.80(c). Documentation In-process inspections, tests, or other verification activities and approvals were not documented.
21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure that equipment is routinely calibrated and maintained were not established and documented.
21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for conducting quality audits were not complete.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance or rejection of incoming product were not implemented.
21 CFR 820.25(b). Training Employees have not been adequately trained.
21 CFR 820.181(c). DMR QA procedures and specifications The device master record does not include or refer to the location of quality assurance procedures and specifications.
21 CFR 820.30(j). Design history file The design history file was not established or maintained.
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(a). DMR device specifications The device master record does not include or refer to the location of all specifications.
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 820.50(a). Evaluation of suppliers, contractors, etc., requirements Adequate quality requirements that must be met by suppliers, contractors, and consultants were not established, defined, documented, and implemented.
21 CFR 820.30(a). Design control - no procedures Procedures to control the design process of the device were not established, documented, and implemented.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits were not conducted at sufficient regular intervals, as prescribed by internal procedures to verify that the quality system is effective in fulfilling your quality system objectives.
21 CFR 820.20. Management responsibility Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization.
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.
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Hialeah, Florida, United States. Part of