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Warning Letter Bulletin

Medical devices

Medical devices 12825W Ambco Electronics, Tustin, CA, Jan. 6 (Los Angeles). During an inspection of the medical device firm, conducted Oct. 4-10, an FDA investigator determined the manufacturer of automatic, semi-automatic and manual audiometers had failed to establish, maintain and control a device-specific quality system. No quality plan defining the quality practices, resources and activities […]

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Warning Letter Bulletin

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