FDA 483 - D R Burton Healthcare LLC - April 11, 2019

B R Burton Healthcare LLC, a medical device manufacturer in Farmville, NC, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately establish and implement procedures for corrective and preventive actions, complaint investigations, process validation, device history records, and in-process product acceptance. Additionally, sampling plans lacked valid statistical rationale, indicating significant issues with their quality management system.