Magnum Health & Safety Pvt. Ltd. Achieves New Milestone with USFDA Audit.

We are pleased to announce that Magnum Health and Safety recently underwent a comprehensive audit conducted by a US FDA auditor (Mr. Charles Larson) from the United States. This thorough audit covered key aspects of our operations, including system processes, hygiene practices, record-keeping, quality management systems, training programs, and Corrective and Preventive Actions (CAPA). The audit primarily focused on the production of our surgical face masks, evaluated under the 510(k) certification process. ?

Key Areas of the Audit:

• System and Process Validation: A detailed review of our manufacturing systems, ensuring they meet global standards for efficiency, reliability, and compliance.
• Hygiene Standards: Rigorous inspection of our facility's adherence to hygiene protocols, critical for maintaining sterility in every stage of production.
• Record-Keeping: Auditing our documentation systems for accuracy, traceability, and transparency in all manufacturing processes.
• Quality Management System: A thorough evaluation of our approach to continuous improvement, ensuring high product quality and customer satisfaction.
• Training Programs: Verification that all employees are fully trained in the latest quality and safety standards, enhancing our production capabilities.
• CAPA (Corrective and Preventive Actions): Review of our methods for addressing any potential issues, ensuring continuous refinement and improvement of our systems.

By successfully completing this comprehensive audit for our surgical face masks, including both Class 1 and Class 2 types, we reaffirm our dedication to providing our customers with products that meet the highest standards of quality, consistency, and hygiene. Our Magnum surgical masks are now US FDA 510(k) approved, making them ideal for use in any pharmaceutical production facility.

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We would like to emphasise that pharmaceutical companies that have US FDA compliance for their production areas must use Magnum's FDA-certified, 510(k) approved face masks to ensure the highest level of hygiene and protection. By integrating Magnum’s masks into your production environment, you enhance safety and compliance, leading to the best possible results in maintaining the cleanliness and integrity of your manufacturing process.

At Magnum Health and Safety, we are committed to continuing innovation and maintaining the highest standards in everything we do. We value your trust and look forward to serving your needs with excellence.

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