FDA 483 - PlasmaLab International, Inc. - August 15, 2019

During an FDA inspection conducted on August 14-15, 2019, PlasmaLab International, Inc. of Everett, WA, received a Form FDA 483 detailing an observation related to their donor adverse event reporting procedures. The primary issue identified was the company's failure to prepare and maintain written reports of investigations into adverse reactions, including conclusions and follow-up actions. Specifically, the inspection revealed instances where donor hematomas occurred during plasmapheresis donations, leading to early termination or unsuccessful donations for three different individuals. Despite these incidents, no Donor Reaction Forms were completed for these donors. This directly contradicted PlasmaLab International's own approved procedure, "Donor Reaction Management," dated October 19, 2016, which mandates the completion of such forms when a donor experiences a hematoma. This observation highlights a deficiency in adherence to internal quality control processes and the proper documentation of adverse events within the plasmapheresis center. The FDA 483 is an official communication outlining conditions or practices observed during an inspection that may indicate non-compliance with regulatory requirements, such as those under the Federal Food, Drug, and Cosmetic Act. PlasmaLab International is now required to address this observation by implementing appropriate corrective and preventative actions to ensure thorough documentation and investigation of all adverse reactions, thereby maintaining compliance and ensuring donor safety.