FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Virginia Devicemaker Slammed for Documentation

May 21, 2019

The FDA hit Virginia Beach devicemaker JBC with a Form 483, citing the company for poor documentation practices.

The agency’s Feb. 5-8 inspection brought to light the documentation issues, including a failure to properly document quality audits and management reviews.

The agency also noted that the firm did not have written supplier evaluation and acceptance procedures as required.

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