Adept Medical Ltd.

Warning LetterOpen

Mr. Murray Fenton Founder, CEO and Guiding Director Adept Medical Ltd. 2-6 Mc Donald Street Morningside Auckland New ZealandFEI 3006098219Issued Oct 11, 2024Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3006098219.

Violations9

Issue DateOct 11, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Adept Medical Ltd.
Location: Mr. Murray Fenton Founder, CEO and Guiding Director Adept Medical Ltd. 2-6 Mc Donald Street Morningside Auckland New Zealand
FEI Number: 3006098219
Country: New Zealand
Issue Date: October 11, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Adept Medical Ltd. manufactured Tympanostomy Tubes (NeoZoline Ventilation Tubes) in violation of current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. An FDA inspection conducted in May 2024 identified failures to establish and maintain adequate procedures for acceptance activities, including incoming inspections and tests, with particular concerns regarding the firm's handling of Biological Indicator certificates of conformance—a deficiency that could compromise the sterilization process and affect product safety and effectiveness. The company's June 2024 response to the FDA's inspectional observations was deemed inadequate to address the identified violations.

Adept Medical Ltd. FDA Warning Letter, October 11, 2024