Zomed Zobel hit with 11-item 483 for GTP and procedure failures.(Biologics)

Zomed Zobel, a manufacturer of bone and joint restoration products, received an 11-item 483 following inspection by FDA investigator Jessica Hensley for failure to properly track and store its products and to establish and follow procedures to meet core GTP requirements. "HCT/Ps are not tracked to facilitate the investigation of transmission of communicable disease and to take corrective actions," the investigator noted on the 483. Further, another item noted that the company had not established, maintained, revised or followed a system "that enables the tracking of HCT/Ps back and forth from the donor to the consignee or final disposition."

Two items noted the …