A history of quality.

PlasmaCare has played a vital role in the plasma collection industry for almost three decades. We are the oldest continuously-operating plasma company in the United States, and we embrace quality assurance at the industry's top levels in our collection centers and at our corporate office.

By investing in state-of-the-art equipment and training to set new standards in product storage and control, we ensure the best quality products at the best possible prices.

Regulatory Requirements

Plasma collection is governed by several regulatory bodies which have strict safety requirements. These organizations include:

• The Food and Drug Administration
  
  
• The Plasma Protein Therapeutics Association
  
  
• Clinical Laboratory Improvement Amendment (CLIA)
  
  
• The European Medicines Agency

Our Requirements

Plasma purchasers must provide specification for the product for testing, storage and shipping temperatures as well as a shipment method. We are willing to supply samples and provide other support functions that may be required for special needs. 

Our Quality

Our entire production processes for donors and units are controlled by our 510k-approved plasma center management system. This system controls the qualifications of the donors and will not allow unqualified donors to donate. It also controls the release of plasma units. If the donor has an issue that requires destruction of the units, testing precludes shipment to the customer, or if the unit is not fully tested to purchaser specifications, the units will not be released. In addition, we have an extensive Quality Management System for review of records, release of product and continuous process improvement.