Multi-Pack Solutions is FDA-registered, MoCRA-compliant, and ISO 13485:2016 certified. We ensure total packaging compliance for pharmaceuticals, medical devices, and cosmetics—backed by 36+ years of regulatory expertise.
Our regulatory framework extends across every product category we manufacture, including OTC drugs, medical devices, and cosmetics. We align our operations with all relevant FDA packaging regulations, ensuring full traceability, stability testing, and documentation for every batch. This commitment allows our partners to bring products to market with the assurance that each step meets FDA and international compliance standards.
Learn more about our certifications, registrations, and dedication to compliance below.
The Multi-Pack Solutions facility in Greenville, South Carolina, is ISO 13485:2016 certified. This certification ensures medical device packaging compliance and quality management and demonstrates our dedication to delivering safe, high-quality devices for our customers. Our ISO certification, combined with FDA registration, provides the regulatory compliance framework necessary for bringing safe, high-quality medical products to market.
Our Greenville, South Carolina facility is FDA-registered and fully compliant with FDA 21 CFR Parts 11, 210, 211, and 820, ensuring full alignment with FDA pharmaceutical packaging regulations and FDA medical device packaging regulations. We are proud of our exceptional history with the FDA and willing to share the details of past inspections with both current and potential customers. Over the last three decades, our team has developed a unique set of FDA-compliant mixing, packaging, and testing capabilities that empower us to deliver consistently high-quality products to customers in a wide range of industries. We maintain complete transparency about our FDA inspection history and regulatory compliance record—available for review by current and prospective customers seeking a trusted FDA-compliant packaging partner.
Our facility is registered with the Environmental Protection Agency and compliant with all applicable regulations for the industries we serve. We push for sustainable manufacturing and packaging.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant advancement in U.S. cosmetic law in decades. Multi-Pack Solutions is fully aligned with these FDA requirements, ensuring that cosmetic products and their packaging comply with updated standards for labeling, traceability, and safety documentation.
Our regulatory team continuously monitors FDA guidance to ensure all cosmetic formulations, packaging materials, and processes meet MoCRA’s evolving expectations. Whether you’re producing single-use sachets or full-size cosmetics, our compliance systems provide the documentation, testing, and reporting your brand needs to stay audit-ready and market safe.
Multi-Pack Solutions maintains a robust quality management system that supports compliance at every step of production. Our regulatory and QA teams oversee material qualification, process validation, labeling review, and post-production documentation to ensure total compliance in our manufacturing, packaging, and laboratory services.
Have a question about our contract manufacturing and custom packaging capabilities? Our team is here to help. You can also learn more by scheduling a consultation today.
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