CSL Plasma Inc. – FDA EIR, Jan 21, 2020

An FDA inspection of CSL Plasma Inc.'s Greensboro, NC facility was conducted from January 15-21, 2020. This comprehensive Level 1 inspection, performed under CPGM 7342.002 for Source Plasma Establishments, reviewed all five operational systems, including documentation for product testing. The facility operates under U.S. License Number 1823. During the inspection, two procedural concerns were identified, though no formal FDA-483 observations were issued. The first involved medical receptionists failing to adequately instruct donors on the proper placement of temperature probes in the sublingual pocket, a requirement outlined in the operator's manual and standard operating procedures. The second issue concerned a Medical Staff Associate who incorrectly documented a donor's medication without proper verification, leading to an initial misidentification of the drug (Lisinopril instead of Losartin), which deviated from the facility's health assessment procedures. In response to these findings, CSL Plasma Inc. management promptly implemented corrective actions. For the temperature probe issue, a training record dated January 17, 2020, confirmed retraining for all receptionists on correct instruction protocols. Regarding the medication error, the affected plasma unit was placed on hold, the donor's medication was verified as Losartin (which was acceptable for donation), and the Medical Staff Associate involved was counseled, with an issue report generated to document the event. These actions were completed and documented prior to the inspection's conclusion.