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Resources

Webinar – Calculating the Cost of Quality for Life Sciences: Perspective From a Former FDA Investigator

Report – Analysis of FDA 483 issued to Cipla Limited

Report – Analysis of FDA 483 issued to Jiangsu Hengrui Pharmaceuticals

Report – Aurobindo’s Quality Problems: A Timeline of Regulatory Actions and Recalls

Webinar – CMO Inspection and Enforcement Trends 2020-2023

Webinar – How to Navigate FDA’s Non-Inspection Enforcement Actions

Law Street | April 10, 2024

This article covers J&J’s acquisition of Shockwave Medical and other cardiac products acquired previously from Impella, which an FDA recall notice linked to at least 49 deaths and 129 serious injuries. Redica Systems provided data and insights for this article. Read the full story here.

Science | March 11, 2024

This article covers the Inspection findings for possible Alzheimer’s drugs by Hoau-Yan Wang, an academic partner of Cassava Sciences. Science contacted Redica Systems to review the findings and get insights from our CEO, Michael de la Torre, and Senior Quality Expert, Jerry Chapman. Read the full article here.

Reuters | March 1, 2024

This article covers problems with Musk’s Neuralink brain implant. Redica Systems provided data and inspection reports for the article. Read the full coverage here.

Webinar – Cultivating Successful Outsourcing Partnerships: The Power of Cultural Fit

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