Quality Systems

All SeraCare facilities are ISO 13485 certified and comply with cGMP regulations. 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 ISO standards and FDA regulations.

Registration and Certification Information

FDA Blood Establishment Registration (Massachusetts #1270029)

FDA Device Registration (Massachusetts #3007088335)

ISO 13485: 2016 (w/ CMDCAS) Certification (FM572228)

EC 1069/2009 and EU 142/2011 Approval
(Massachusetts #MA-TEC-0003; Maryland #MD-TEC-0002)

Massachusetts Board of Pharmacy License (Massachusetts #WD463)