www.fdanews.com/articles/191358-virginia-devicemaker-slammed-for-documentation
Virginia Devicemaker Slammed for Documentation
May 20, 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.