Regulatory Affairs

From ISO certification to total FDA and EPA compliance, no one takes regulatory compliance and quality assurance more seriously than our team.

regulatory meeting

Overview

Total Regulatory Compliance for Total Peace of Mind

With nearly 35 years of contract manufacturing and packaging expertise, our team understands the importance of quality and traceability. That’s why our dedication to regulatory compliance extends throughout our entire organization. Our Greenville facility is ISO 13485:2016 certified, EPA registered, fully FDA compliant, and FDA Drug and Medical Device registered. Our track record of compliance serves as a testament to our commitment to quality, giving our customers complete confidence that they’re always receiving a best-in-class product.

The Multi-Pack Advantage

ISO

ISO 13845:2016 Certified

EPA

EPA Registered

FDA

Fully FDA Compliant

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FDA Drug & Medical Device Registered

Quality

Our Regulatory Compliance

Learn more about our certifications, registrations, and dedication to compliance below.

ISO Certification

The Multi-Pack Solutions facility in Greenville, South Carolina, is ISO 13485:2016 certified. This certification addresses the medical device directives, regulations, and responsibilities of our facility. It also demonstrates our dedication to delivering safe, high-quality devices for our customers.

FDA Compliance

Our Greenville, South Carolina, facility is registered with the FDA and fully FDA compliant to FDA 21 CFR Part 11, 210, and 211 for drugs, as well as 820 for medical devices. 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.

EPA Registration

Our facility is registered with the Environmental Protection Agency and compliant with all applicable regulations for the industries we serve.

multipack employee on floor