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Medical Devices / Submissions and Approvals

FDA Warns MiBo Medical for Design Controls, CAPAs

Dec. 10, 2018

Seven months after issuing a Form 483 to MiBo Medical Group following an inspection of its Dallas, Texas facility, the FDA warned the devicemaker that it had not fully addressed the problems with design control procedures, CAPA procedures or complaints.

After reviewing the firm’s initial responses to the May inspection, the FDA found insufficient evidence that the devicemaker had complied with requirements for design controls.

The inspectors found the facility lacked a description for design or development activities. The warning letter also noted that the facility lacked written CAPA procedures.

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