Quality and Compliance Assurance
Since 1999, Therapak has been earning the respect and trust of its customers with a harmonized Global Quality Management System (QMS) which is reviewed during internal audits and customer audits. Therapak has three strategically positioned facilities in Los Angeles, Atlanta and Prague to offer our customers a reliable and compliant environment for supply management & distribution solutions with a built-in Business Continuity Plan. Therapak’s regulatory certifications are identified below:
Location | Certification | Reference No. |
Claremont, CA | State of California Department of Health Services, Food and Drug Branch, Device Manufacturer License | 74204 |
Claremont, CA | California State Board of Pharmacy Wholesaler license | WLS 6993 |
Claremont, CA | Food and Drug Administration Department of Health and Human Services Owner/Operator | 9002081 |
Claremont, CA | Food and Drug Administration Department of Health and Human Services Registered Establishment | 3010882984 |
Buford, GA | Food and Drug Administration Department of Health and Human Services Owner/Operator | 9002081 |
Buford, GA | Food and Drug Administration Department of Health and Human Services Registered Establishment | 3006450277 |
Prague, CZ | State Institute for Drug Control (SÚKL) Importer of diagnostic medical devices in vitro, Distributor of diagnostic medical devices in vitro, registration | 006322 |
Claremont, CA | State of California Department of Health Services, Food and Drug Branch, Device Manufacturer License | 74204 |
Claremont, CA | California State Board of Pharmacy Wholesaler license | WLS 6993 |
Buford, GA | Food and Drug Administration Department of Health and Human Services Owner/Operator | 9002081 |
Buford, GA | Food and Drug Administration Department of Health and Human Services Registered Establishment | 3006450277 |
Prague, CZ | State Institute for Drug Control (SÚKL) Importer of diagnostic medical devices in vitro, Distributor of diagnostic medical devices in vitro, registration | 006322 |
It is our policy to consistently deliver products and services that fully meet Customer specifications, company policies and procedures and regulatory requirements for the assembly and distribution of medical devices, convenience kits and procedure packs. Therapak will ensure our Client’s confidence by remaining current with supply chain developments, optimizing training methods, monitoring key quality performance metrics and continually improving our processes and services as part of an effective Quality Management System.
Therapak’s Quality Management System has been developed in compliance with regulatory standards to meet the needs of our global customer base and to improve the management practices of our company. The quality system operates in accordance with the United States Food and Drug Administration’s current Good Manufacturing Practices for medical devices – 21 CFR § 820, and Article 12 of Council Directive 93/42/EEC concerning medical devices, commonly referred to as the Medical Device Directive (MDD).