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

On August 14-15, 2019, the FDA inspected PlasmaLab International, Inc., a plasmapheresis center located at 3128 Norton Ave, Everett, WA 98201-4216. The inspection was conducted by Investigator Peter S Kessler and the report was issued to Kay C. Hill, CEO.

The inspection revealed one observation: written reports of investigations of adverse reactions, including conclusions and follow-up, were not prepared and maintained. Specifically, donor records for (b) (6), (b) (7)(C) and (b) (6), (b) (7)(C) showed hematomas in both arms during donations on (b) (6) and (b) (6), (b) (7)(C) respectively, resulting in early termination or unsuccessful donations. No Donor Reaction Forms were completed for these three donors, despite the firm's "Donor Reaction Management" procedure (approved 10/19/2016) requiring completion of such forms for hematomas. This observation was based on a review of 20 donor records.