Inspection Dates: October 22–24, 2025
Regulatory Authority: United States Food and Drug Administration (FDA)

Demonstrating Our Commitment to Quality and Compliance

Health Source is proud to announce the successful completion of a United States Food and Drug Administration (FDA) inspection conducted at our facilities from October 22 to 24, 2025. This routine regulatory audit underscores our ongoing commitment to maintaining the highest standards of quality, safety, and operational excellence.

Comprehensive Review of Operations

During the inspection, the FDA conducted a thorough evaluation of our core systems and processes, including:

• Manufacturing operations and process controls

• Quality assurance and quality control systems

• Data integrity and documentation practices

• Equipment qualification and maintenance

• Personnel training and compliance

• Material management and product traceability

This comprehensive review reflects the robustness of Health Source’s quality management systems and our alignment with current Good Manufacturing Practices (cGMP).

Inspection Outcome and Proactive Response

At the conclusion of the inspection, a Form 483 was issued, identifying observations for further improvement. Health Source views this outcome as an integral part of the regulatory process and an opportunity to enhance our systems even further.

We responded promptly and comprehensively to all observations, implementing targeted Corrective and Preventive Actions (CAPA) designed to strengthen operational controls, reinforce data governance, and optimize quality systems. These actions have already been completed or are in advanced stages of implementation.

Continuous Improvement as a Core Principle

At Health Source, regulatory inspections are not simply compliance checkpoints—they are catalysts for continuous improvement. Following the FDA audit, we have:

• Further enhanced our quality management framework

• Expanded employee training and competency programs

• Strengthened internal audit and risk assessment processes

• Advanced our commitment to data integrity and transparency

Building Trust Through Excellence

The successful completion of this FDA inspection reinforces Health Source’s dedication to delivering safe, reliable, and high-quality products to our customers and partners worldwide. We remain committed to exceeding regulatory expectations and continuously advancing our standards.

Health Source will continue to engage proactively with global regulatory authorities while driving innovation, quality, and trust across all aspects of our business.

Health Source
Quality & Compliance Division