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Medical Devices / Inspections and Audits

FDA Reveals Quality Management Issues at Zeus-MJB

Jan. 9, 2018

An FDA site inspection at Zeus-MJB’s manufacturing facility in California revealed several noncompliance issues associated with its quality management systems.

As of late September 2017, the firm did not have procedures for executive management to conduct routine reviews of its quality system in order to ensure compliance with established policies.

Procedures for performing internal quality audits had not been established either.

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