03.23.23 -- Trends In FDA FY2022 Inspection-based Warning Letters

The EU's new Directive 2022/2555 on the Security of Network and Information Systems (NIS2) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs, CROs and CDMOs, and manufacturers of APIs, biopharmaceuticals, and medical devices.

We analyzed the warning letters that the FDA issued to pharmaceutical and biotech companies in FY2022. Several key trends emerged, including a heightened scrutiny on two product types.