FDA 483 - Reprobiotech Corp - September 05, 2019

Reprobiotech Corp in Flushing, NY, a developer and manufacturer of embryo storage containers, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included a lack of established procedures for critical quality activities, inadequate purchasing controls for contract manufactured products, and insufficient documentation for contractor evaluations and agreements. Additionally, the firm failed to develop written procedures for Medical Device Reporting of adverse incidents.