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Medical Devices / Inspections and Audits

FDA Cites Illinois Devicemaker for Design Control Procedures

July 11, 2019

The FDA hit Evanston, Illinois device manufacturer Dot International with a Form 483 for lacking design control procedures.

During a Feb. 25-26 inspection, the agency was told by the firm’s owner that the facility had not established or maintained design control procedures for managing design planning and development, design transfer and design validation and verification.

The firm also failed to maintain a device master record for its menstrual cup product, a class II medical device.

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