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All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards.
Our products are completely traceable, from sourcing through processing to delivery—providing a high level of confidence, quality, and safety.
Test records—at the donor unit, pooling, and finished product stages—are maintained by our quality assurance department in accordance with FDA regulations.
SeraCare’s broad scope of products reduces variability in your process of validation, discovery, and production.
Our tagline says it best: “Quality is in our blood.”
Summary Sheet of Our Quality Systems
Certifications for Milford, Massachusetts
Certifications for Frederick and Gaithersburg, Maryland
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