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

**FDA 483 Summary for PlasmaLab International, Inc.**

**Inspection Overview:** - **Company:** PlasmaLab International, Inc. - **Location:** 3128 Norton Ave, Everett, WA 98201-4216 - **Inspection Dates:** August 14-15, 2019 - **Type of Establishment:** Plasmapheresis Center - **FDA Contact:** Peter S. Kessler, Investigator

**Key Observations:** During the inspection, the FDA identified significant compliance issues related to the management of adverse reactions in donors. Specifically, the facility failed to prepare and maintain written reports of investigations for adverse reactions, such as hematomas experienced by donors during the plasmapheresis process. The facility's procedure, "Donor Reaction Management," mandates the completion of a Donor Reaction Form when such incidents occur, which was not adhered to for three donors.

**Regulatory Framework:** The inspection was conducted under Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)), which requires FDA representatives to report any objectionable conditions or practices observed during inspections. These observations are intended to assist firms in complying with FDA regulations and ensuring the safety and efficacy of their operations.

**Required Actions:** PlasmaLab International, Inc. must address the identified deficiencies by implementing corrective actions to ensure compliance with FDA regulations. This includes the preparation and maintenance of comprehensive written reports for all adverse reactions, as stipulated in their internal procedures. The company is encouraged to discuss any objections or corrective actions with the FDA representatives or submit documentation to the FDA at the provided address.

**Conclusion:** The FDA's observations highlight the need for PlasmaLab International, Inc. to enhance its procedures for managing donor reactions to ensure regulatory compliance and safeguard donor health.