FDA 483 - Safecor Health, LLC - June 24, 2024

Safecor Health, LLC, a drug repackager in Woburn, MA, received a Form 483 for multiple deficiencies observed during an FDA inspection. The firm was cited for inadequate procedures regarding customer complaint handling, insufficient qualification and requalification of critical drug storage refrigerators, and failure to complete annual product reviews in a timely manner. These observations highlight significant issues in the firm's quality system and adherence to cGMP regulations.