consistent with clarification in FDA memo of 11-25-02.
Inventory as of this Action
The information collection
requirements in the CGMP regulations and lookback requirements
provide FDA with the necessary information to perform its duty to
ensure the safety, purity, and potency of blood and blood
components. These requirements establish accountability and
traceability in the processing and handling of blood and blood
components and enable FDA to perform meaningful inspections. The
recordkeeping requirement serve preventative and remedial purposes.
The disclosure requirements identify the various blood and blood
components and important properties of the product, demonstrate
that the CGMP..........