High purity chemicals for the pharmaceutical, biotech, diagnostics, and food & beverage industries.

Quality

FDA Certification & ISO Registration

At Barker Industries, compliance is at the core of how we do business. As an FDA-registered and ISO-certified chemical manufacturer, we uphold the highest standards of quality, safety, and regulatory integrity to support our customers across pharmaceutical, biotech, diagnostic, and industrial markets.

FDA-Registered Facility

Barker Industries is proud to be registered with the U.S. Food and Drug Administration (FDA). Our manufacturing operations are conducted in accordance with 21 CFR Parts 210 & 211, ensuring full compliance with Good Manufacturing Practices (GMP).

What this means for you:

  • Products manufactured in a GMP-compliant environment

  • Full traceability and documentation from raw materials to finished goods

  • Support for regulatory inspections and customer audits

  • Quality systems aligned with FDA expectations for pharmaceutical and life science applications

ISO 9001:2015 Certified Quality System

Our operations are governed by an ISO 9001:2015-certified Quality Management System, which demonstrates our ongoing commitment to continuous improvement, risk management, and customer satisfaction.

ISO Certification Highlights:

  • Internationally recognized framework for quality management

  • Risk-based thinking embedded in all processes

  • Documented procedures, records, and quality objectives

  • Third-party audits to ensure compliance and effectiveness

  • Cross-functional accountability from production to packaging

Documentation & Regulatory Support

We provide the documentation and transparency our customers need to meet their internal and external regulatory requirements.

Available on request:

  • FDA Registration Number & ISO Certificate

  • Certificates of Analysis (CoAs) & Safety Data Sheets (SDS)

  • cGMP Manufacturing Statements

  • Validation Support & Quality Agreements

Trusted by Regulated Industries

Whether you’re manufacturing active pharmaceutical ingredients, diagnostic reagents, or specialty chemical blends, you can count on Barker Industries to deliver consistent, compliant, and audit-ready solutions.

Partner with a Certified Manufacturer You Can Trust

Our certifications are more than just paperwork—they represent our commitment to delivering safe, high-quality products you can rely on.

📄 Need a copy of our FDA registration or ISO certificate?
Contact us and we’ll provide the documentation you need for regulatory assurance.