FDA AND ISO QUALITY MANAGEMENT SYSTEMS

Certifications/Registrations

  • FDA Registered and Inspected for food processing and pharmaceutical API/Excipients

  • Manufactured in full compliance with FDA cGMP requirement for Finished Pharmaceutical and API.

  • Manufactured in full compliance with FDA requirements for Food Safety and HARPC.

  • REACH registered

  • Kosher Certified

  • ISO 9001

  • ISO 14001

Documentation/Validations

  • Master Validation Plan of Quality Management System QMS & SAP

  • Calibration program

  • QT9 Documentation Software

  • CAPA Program

  • Validated production process

  • Validated water systems

  • Validated analytical methods, systems and processes. 

Full FDA Compliant Batch Documentation for all Customer Orders

  • Batch and lot production tracking

  • Full traceability of components/ingredients, from raw materials to finished product shipments to customers.

  • All internal analytical results periodically verified by accredited independent 3rd party laboratories.

QUALITY ASSURANCE CONTACT

If you have any QA related issues or would like to audit us, please email: qa.ashtabula@italmatch.com

Detrex Chemicals
A Division of Detrex Corporation
1000 Belt Line Street 
Cleveland, Ohio 44109 USA

Phone: 1.800.321.0467
Fax: 1.216.749.7462
Email Sales

Email Corporate & Human Resources

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