For Blood / Biologics

HCT/P Inspections: Most Common Deviations

Total of 36 Product Recalls Last Year for HCT/P Sector

The FDA issued a total of 36 product recalls of HCT/Ps (human cell, tissue, and cellular and tissue-based products) last year and shut down two tissue-recovery firms because of serious Good Tissue Practice violations, according to the Center for Biologics Evaluation and Research (CBER).

Out of the 36 product recalls, 13 were Class I recalls, 22 were Class II, and one was Class III, according to Mary Anne Malarkey, director of CBER’s Office of Compliance and Biologics Quality, during a presentation at the Third Annual “FDA and the Changing Paradigm for HCT/P Regulation” conference last January.

Class I means there’s a strong likelihood that use of, or exposure to, the product in violation will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible adverse health consequences, while Class III means the product is not likely to cause adverse health consequences.

Out of the 13 Class I product recalls, nine were related to HCT/Ps recovered by Biomedical Tissue Services (BTS) of Fort Lee, N.J. Last year, the FDA ordered BTS and Donor Referral Services of Raleigh, N.C., to cease all manufacturing operations. DRS had serious manufacturing deficiencies in the areas of donor screening and record keeping. BTS also had donor-screening and record-keeping violations, and it failed to follow its own SOPs.

Malarkey discussed common deviations among HCT/P establishments that have led to regulatory action during fiscal year 2006. They include:

  • Failure to establish and maintain procedures [21 CFR 1271.47 (a) and 180 (a)] in such areas as:

    • Donor eligibility determination;
    • Donor screening;
    • Donor testing;
    • Plasma dilution; and
    • Recovery.

  • Failure to establish and maintain accurate records [1271.55 (d) and 270 (a)] such as:

    • Medical evaluation forms;
    • Physician interviews;
    • Next-of-kin interviews; and
    • Recovery records.

  • Inadequate screening for risk factors/clinical evidence of communicable disease [1271.75 (a)]

  • Acceptance of product from ineligible donors [1271.50]

  • Failure to recover in a way that does not cause contamination or cross-contamination [1271.215]

  • Donor-testing deviations such as:

    • Not testing for communicable diseases [1271.85];
    • Not using FDA licensed/approved/cleared kits [1271.80(c)]; and
    • Incorrect timing of specimen collections [1271.80 (b)].

Read other articles for the blood, biologics, and tissue industry:

Case Study :

The Institute for Transfusion Medicine (ITxM)

Compliance with FDA's Good Tissue Practice Regulations

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FDA Link

  • CBER Presentation: FDA HCT/P Inspection Experience

Additional Article