FDA 483 - Upstate New York Transplant Services Inc - July 01, 2021

Upstate New York Transplant Services, Inc., a human tissue establishment and blood center in Buffalo, NY, was cited for significant deficiencies during an FDA inspection. The firm failed to use FDA-licensed, approved, or cleared donor screening tests for communicable diseases, specifically syphilis. Additionally, the quality program did not ensure appropriate corrective actions were taken in response to notifications about unapproved HIV and syphilis screening tests from a third-party laboratory.