FDA 483 - Trix Manufacturing, Inc. - May 23, 2002

Trix Manufacturing, Inc. in Jacksonville, SC, a drug manufacturer, was cited for multiple deficiencies during an FDA inspection. The observations primarily focused on the firm's failure to ensure the authenticity, integrity, and security of electronic records and the lack of validation for computer systems. Additionally, the firm lacked proper audit trails and written procedures for product distribution and release criteria.