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# QS, MDR, Other Violations in Medivance Inspection
- URL: https://www.fdaweb.com/qs-mdr-other-violations-in-medivance-inspection/
- Published: 2023-04-25T12:00:00.000Z
- Updated: 2026-09-14T18:27:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154289

An 8/8-8/11/22 FDA inspection at Medivance Instruments in London, UK, determined that the firm manufactures the Velopex Aquacut Fluid Abrasion Unit and accessories as part of its Velopex AquaCare dental abrasion line of products. A just-released 2/13 Warning Letter says the firm holds a 510(k) clearance for the Velopex device, but it has been, in multiple ways, significantly changed or modified in design, components, method of manufacture, or intended use in ways that could affect its safety or effectiveness.

The letter says the firm did not submit a required new 510(k) based on the changes and modifications. It also says the modified Velopex devices are adulterated because Medivance does not have an approved PMA or IDE in effect.

Quality System Regulation violations identified during the inspection were:

- failing to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation;
- failing to establish and maintain procedures for implementing corrective and preventive action;
- failing to review and evaluate all complaints to determine whether an investigation is necessary and, when no investigation is made, maintaining a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate; and
- failing to maintain device history records for each batch, lot, or unit to demonstrate that the device was manufactured per the device master record.

Medical Device Reporting (MDR) violations found in the inspection were:

- failing to submit an MDR report no later than 30 calendar days after receiving or becoming aware of information that reasonably suggests that a marketed device either may have caused or contributed to a death or serious injury, or has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; and
- failing to develop, maintain, and implement written MDR procedures.

Medivance was told to take prompt action to address the violations identified in the letter and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.