FDA 483 - JAK Diversified II Inc. - January 31, 2011

An FDA inspection of JAK Diversified, L.L.C. DBA Multi-Pak Packaging, L.L.C. in Fairfield, NJ, an OTC repacker, revealed significant deficiencies in their manufacturing and quality control systems. The firm lacked essential written procedures for process and cleaning validations, failed to retain required batch records, and did not adequately manage reprocessing or conduct annual visual examinations of retain samples. Additionally, the company failed to provide documented cGMP training for its employees.