FDA Inspects Claremont Facility: No Observations Reported

Claremont, CA., December 11, 2017 – Last week the United States Food and Drug Administration performed a Level 2 baseline (Comprehensive) inspection of Therapak’s Claremont, California facility. Conducted 04-Dec-17 – 05-Dec-17, the inspection was reported as NAI (No Action Indicated) and did not result in the issuance of a FDA-483. This was Therapak’s third regulatory inspection in less than 3 years and follows previous US FDA inspections in California in 2015 (Level 2), 2010 (Level 1) and 2005 (Level 2). Therapak’s Buford, GA facility was also inspected in 2016 (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 to be your partner in supporting your kit manufacturing and distribution needs, and will continue doing our part to ensure we provide you with a compliant solution to support your kit supply chain needs. For more information, contact us at info@therapak.com

Acquired by VWR in 2016, Therapak supplies pre-packaged convenience kits and procedure packs for the clinical trial, pharmaceutical, diagnostic and clinical laboratory industries.