Claremont, CA., July 15, 2016 – Therapak, a leading supplier of pre-packaged convenience kits and procedure packs for the clinical trial, pharmaceutical and clinical laboratory industries announced the United States Food and Drug Administration performed a Level 2 baseline (Comprehensive) inspection of Therapak’s Buford, Georgia facility. Conducted 29-Jun-16 – 30-Jun-16, the inspection did not identify any deficiencies and did not result in the issuance of a FDA-483. This was Therapak’s first regulatory inspection in Buford but follows previous US FDA inspections in California in 2015 (Level 2), 2010 (Level 1) and 2005 (Level 2).
Processes and procedures were reviewed and records sampled to evaluate compliance with 21 CFR § 820. Specific subsystems covered included:
- Management Responsibility;
- Production and Process Control;
- Complaints; and
- Corrective and Preventative Actions (CAPA)
“Therapak is proud of the successful outcome of the inspection and we salute the performance of our RA/QA leadership and all of our associates who collectively contribute to our Quality Management System. We are part of a large regulated industry that strives to improve the health and wellness of a global community and it is gratifying to receive a confirmation that our quality objectives and business goals are aligned in terms of compliance and performance for the benefit of that community”, said Todd Gates, President of Therapak.
Therapak provides comprehensive kit development, branding, digital requisition printing, fulfillment system technology, logistics management and tracking solutions for the laboratory and pharmaceutical supply chain. Our mission is to help you succeed in delivering quality healthcare products and services on a global basis. For more information, contact us at firstname.lastname@example.org