US FDA Material and supplier control findings

Failure to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their Certificate of Analysis.

Failure to ensure that all specifications are scientifically sound and appropriate to ensure that your raw materials and API conform to established standards of quality and purity.

Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Written standard operating procedures including all steps to be followed in the storage of blood and blood components for further manufacturing purposes were not always maintained and followed.

Written standard operating procedures including all steps to be followed in the compatibility testing and distribution of blood and blood components for allogeneic transfusion were not always maintained.

Written standard operating procedures including all steps to be followed in the distribution of blood and blood components for allogeneic transfusion were not always followed.