FDA halts manufacturing at Biomedical Tissue Services

In an unprecedented move, the US Food and Drug Administration (FDA) has ordered Biomedical Tissue Services (BTS) and Michael Mastromarino, its ceo and executive director of operations, to immediately cease all of its manufacturing of human tissue and cellular and tissue based products (HCT/Ps).

The human-tissue recovery company, based in Fort Lee, New Jersey, US, has had all its tissue products recalled, and the FDA is monitoring all recalls to account for all of the tissue distributed.

'FDA's investigation of BTS revealed serious and widespread deficiencies in their manufacturing practises that provide the agency with reason to believe that allowing the firm to manufacture would present a danger to public health by increasing the risk of communicable disease transmission,' said Margaret O'K. Glavin, FDA's associate commissioner for regulatory affairs.

The FDA reported violations of regulations governing donor screening and record keeping practices, as well as failures by BTS to follow its own standard operating procedures (SOPs); recover HCT/Ps in a manner that does not cause contamination or cross-contamination during recovery, and adequately control environmental conditions.

Despite records maintaining otherwise, BTS was found to have 'inadequately screened' donors for risk factors for, or clinical evidence of, disease agents and diseases. Death certificates in the company's files were also found to differ from death certificates obtained by the FDA, stating different causes, places, and times of death.

The FDA is continuing its investigation of BTS' activities, working with tissue processors and federal, state and local authorities.