FDA 483 - CSL Plasma Inc. - March 21, 2019

An FDA inspection conducted at CSL Plasma, Inc. in Linden, New Jersey, from March 19-21, 2019, identified several observations indicating a lack of adherence to their established standard operating procedures. The inspection, documented in an FDA Form 483, highlighted three main issues. Firstly, the firm's Quality Department did not consistently follow procedures for contacting donors with unacceptable test results. Specifically, for a deferred donor who received an STS counseling packet but did not return for required testing, only one contact attempt was made via phone, failing to utilize alternative contact methods as mandated by SOP PE-SOP-0001. Secondly, employees failed to inspect a damaged box of supplies to assess its suitability for use, contrary to SOP ES-WI-0002 on Supply Management. This lapse could potentially compromise product quality or donor safety. Finally, an investigation into a donor overharvest, a critical safety concern, was not completed within the required two-day timeframe from discovery, violating SOP DF-SOP-0001. This indicates a delay in addressing significant events. These observations collectively suggest deficiencies in quality system oversight and procedural compliance. While the FDA 483 itself does not mandate specific actions, CSL Plasma, Inc. is expected to promptly investigate these findings, implement comprehensive corrective and preventive actions, and ensure full compliance with their internal procedures and federal regulations to maintain product quality and donor safety.