FDA establishment 2020808, Santee, California, United States. Part of Scantibodies Laboratory's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 640.61. Written consent Failure to obtain written consent of prospective Source Plasma donors.
21 CFR 606.100(c). Record review prior to release All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product.
21 CFR 601.12(f)(1). Labeling changes Failure to receive FDA approval before distributing the product with labeling changes.
21 CFR 606.20(b). Qualifications of responsible personnel The personnel responsible for the collection, processing, storage, and distribution of blood or blood components are not adequate in training and experience, including professional training as necessary to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess.
21 CFR 640.65(b)(3). Donor identification system Failure to establish a donor identification system that positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection, processing, storage, and distribution of blood and blood components for further manufacturing purposes are not always followed.
21 CFR 640.72(d). Donor reaction Failure of the donor record to contain a full explanation of a donor reaction, while on the plasmapheresis premises or reported to the center after the donor has left the premises, including the measures taken to assist the donor and the outcome of the incident.
21 CFR 640.65(b)(2)(i). Physician review of four month sample Failure of the physician or physician substitute to review and sign the plasma or serum protein electrophoresis data and collection records within 21 days after the sample was drawn.
21 CFR 820.80(e). Documentation Acceptance activities were not adequately maintained as part of the device history record.
21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated have not been adequately established.
21 CFR 820.40(a). Not approved or obsolete document retrieval Documents that were not approved were observed at a location where they are being used.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
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