Blood/biologics.

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Baxter Healthcare Corp., Westlake Village, CA, May 11 (APLB). CBER's Advertising and Promotional Labeling Branch reviewed a professional print advertisement for the company's product Polygam S/D [Immune Globulin Intravenous (Human)], and found the advertisement failed to include risk information and contained misleading statements that "could encourage the unsafe use of Polygam S/D." Polygam S/D is a solvent/detergent treated, sterile, freeze-dried preparation of highly purified immunoglobulin G (IgG) derived from human plasma. According to the Contraindications section of the PI, patients may experience severe hypersensitivity reactions or anaphylaxis in the setting of detectable IgA levels following infusion. Polygam S/D is associated with numerous risks, including serious and sometimes fatal risks of renal dysfunction, acute renal failure, osmotic nephrosis, severe hypersensitivity reactions or anaphylaxis and infectious disease, the agency said. However, according to the warning letter, the main part of the print advertisement made numerous claims of safety and effectiveness, but failed to provide any risk information. Moreover, the advertisement stated that Polygam S/D "has one of the lowest IgA content levels of any IgIV product to accommodate patients with antibodies to IgA or selective IgA deficiencies." FDA found this statement misleading because is appears in the main body and is not accompanied by the pertinent qualifying information from the PI regarding patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern. Moreover, that same statement was not accompanied by the pertinent qualifying information from the PI regarding the risk of anaphylaxis in patients with antibodies to IgA or IgA deficiencies that are a component of an underlying primary immunodeficiency disease for which IGIV therapy is indicated. F-B 

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Hunterdon Medical Center, Flemington, NJ, May 3 (Central Region). During a Jan. 29 to Feb. 12 inspection of the unlicensed blood bank, the agency noted significant deviations from the current GMP regulations for Blood and Blood Components, which included failure to maintain accurate records to identify unsuitable donors. According to the warning letter, the facility failed also to maintain records to establish scientifically sound and appropriate specifications, standards and test procedures; test records to support the installation and validation performed were not maintained at the facility; and there were no written procedures or formal instructions describing operation, maintenance and calibration of units. Moreover, FDA said the facility failed to maintain equipment used in the processing of blood and blood products to facilitate cleaning and maintenance. Also, there was no documentation to support that start-up and shutdown procedures were performed for testing runs conducted on April 9, 11, 17 and 24, 2003. The blood bank was further cited because it did not submit a biological product deviation report within 45 days from the date that staff discovered a unit was labeled with an incorrect expiration date. The FDA investigator determined the numbers were transposed when entered into the computer system. Additionally, a Laboratory Incident Form, which requires a documented supervisory review and recommendation to prevent reoccurrence of similar incidents, was not filed. Lastly, Hunterdon Medical was hit with failure to establish adequate procedures for preparing the phlebotomy site in a manner to give maximum assurance of a sterile environment. Cal, QC/QS, Ster

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Our Lady of the Lake Hospital, Inc., Baton Rouge, LA, May 7 (New Orleans). During an inspection of the hospital blood bank, on March 30 and April 2, 5-8, 2004, an FDA inspector documented several GMP violations. The deviations included the facility failed to perform a thorough investigation and make a record of the conclusions and follow-up of unexplained discrepancies. The agency said the blood bank did not have records to document that blood /blood components from the donations were quarantined pending determination of donor suitability. Moreover, records were not concurrently maintained with the performance of each significant step in the collection and processing of each unit of blood and blood components; and the facility failed to maintain written SOPs, including all steps to be followed in the collection, processing, storage and distribution of blood and blood components for homologous transfusion, autologous transfusion and further manufacturing purposes. Lastly, the warning letter pointed out the facility failed to assure that equipment was performing properly and in the manner for which it was designed. The facility did not have any validation data to support the current testing of non-citrate anti-coagulated blood samples. QC/QS, Val