FDA 483 - Biomedix Wai - October 31, 2019

Biocodix WAI received an FDA Form 483 citing multiple deficiencies primarily related to inadequate process validation, quality system procedures, and equipment controls. Key issues include insufficient validation of sealing processes, lack of monitoring for validated parameters, inadequate handling of non-conforming products, and deficiencies in supplier and change control. The report highlights repeat observations from previous inspections, indicating persistent quality system failures.