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# Multiple Adept Medical Violations Cited
- URL: https://www.fdaweb.com/multiple-adept-medical-violations-cited/
- Published: 2024-11-26T12:00:00.000Z
- Updated: 2026-09-14T14:48:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158262

A 5/13-5/16 FDA inspection at Adept Medical Ltd. in Auckland, New Zealand, found Quality System Regulation and other violations in the firm’s manufacturing of NeoZoline ventilation tubes. A just-released 10/11 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/adept-medical-ltd-692226-10112024?ref=fdaweb.com) says specific violations were:

- failure to establish and maintain procedures for acceptance activities, which include inspections, tests, or other verification activities;
- failure to ensure that where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures;
- failure to establish and maintain procedures for implementing corrective and preventive action;
- failure to establish and maintain procedures to control product that does not conform to specified requirements, including the identification, documentation, evaluation, segregation, and disposition of nonconforming product, and failure to ensure that the evaluation includes a determination of the need for an investigation; and
- failure to define the type and extent of control over the product, services, suppliers, contractors, and consultants, based on the evaluation results.

The letter says the firm’s responses to the inspection observations were inadequate. FDA also found that the company does not have an approved application for PMA or IND in effect for its NeoZoline tubes. It also did not notify FDA of a significant change or modification to the device that could significantly affect its safety or effectiveness.

Adept was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrective actions and a schedule for their completion.