FDA EIR - Oregon Health & Science University - July 17, 2018

Oregon Health & Science University (OHSU) underwent an FDA inspection from July 16-17, 2018, covering its registered blood irradiator, hospital transfusion service, and human tissue establishment. The inspection was conducted under the Office of Biological Products Operations FY 2018 workplans and relevant Compliance Programs for blood banks (7342.001) and human cells, tissues, and cellular and tissue-based products (7341.002).

Notably, the inspection concluded without any observations, meaning no Form FDA 483 was issued, and no new violations were identified. This contrasts with the previous inspection on January 28, 2016, which resulted in a Form FDA 483 for issues including undocumented preventative maintenance for blood storage and processing equipment, inconsistencies between standard operating procedures and equipment manuals, and late submission of two biological product deviation reports. These prior issues were addressed and not observed during the current inspection, indicating effective corrective actions by OHSU.

During the current review, OHSU's operations, including quality assurance, storage, product testing, and component preparation, were assessed. The firm was advised to adjust its human tissue registration to omit cranial bone flaps and parathyroid tissue, based on current practices aligning with same surgical procedure exceptions, while continuing registration for other cellular and therapeutic products.

The overall outcome of the 2018 inspection was positive, with no regulatory actions required or observations noted.