


Information Request, Product Quality, August 12, 2011 - Gintuit

 
 
  Please provide a comprehensive table that lists the location of all 
  information present in existing FDA regulatory files on Apligraf (PMA) or 
  CelTx (IDEs, BLA) relevant to growth factor, cytokine or extracellular matrix 
  protein released by the final product. Both non-clinical and clinical 
  information should be included.

 
  Please provide a comprehensive table that lists all of the fibroblast and 
  keratinocyte cell banks that have been used for the manufacture of Apligraf to 
  date and of CelTx during the IDE studies. In the table, please also include 
  the following information:

 
     S/N and submission date of the supplement to the FDA file that contains the 
    testing data

 
    An indication of any points at which the testing of the cell banks were 
    modified

 
  Please provide the validation reports of analytical procedures for the 
  following final product release specifications outlined in Table 3.2.P.5.1-1 
  of the BLA submission:

 
    QCP-072- Mycoplasma, performed by -----b(4)--------------------------

 
    QCP-002- Sterility USP <71> (Bacteriostasis / Fungistasis test), performed 
    by      ----b(4)---------------------------------------------. Only the 
    summary of tests has been provided.

 
    QCP-053- Visual inspection
 
