FDA 483 - CSL Plasma, Inc.

CSL Plasma, Inc. in Rochester, New York, was cited for deficiencies in its plasmapheresis operations. The inspection revealed that serologic tests for syphilis and protein electrophoresis were not consistently performed on the day of initial donation, leading to unsuitable units not being identified. Additionally, the firm failed to ensure timely and complete donor notification of all test results and lacked adequate written procedures for this process.