Plascon, Inc., dba Anderson Plasma Center; Denial of Request for a Hearing and Revocation of U.S. License No. 572-003

Streszczenie

The Food and Drug Administration (FDA) is denying the request for a hearing and revokes the establishment license (U.S. license number 572-003) and product license issued to Plascon, Inc., doing business as Anderson Plasma Center, for the manufacture of Source Plasma. The agency finds that there is no genuine and substantial issue of fact justifying a hearing on the revocation of Plascon's licenses. The licenses are revoked due to the firm's failure to comply with the applicable biologics regulations and license standards designed to ensure the safety, purity, and potency of the manufactured products.