What FDA Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025)
What’s in this analysis
This trends write-up uses only the audit reports in this project set from late spring–summer 2025. The set includes audit engagements across distinct contexts:
- Mock pre-approval/readiness audits at drug-product manufacturing sites.
- A corporate/internal QMS audit at a sponsor HQ overseeing a combination-product portfolio.
- Supplier qualification audits at a clinical-supply/secondary-packaging facility.
- ICH GCP investigator site audits.
No company or site names are used here, and we haven’t added any facts beyond what those reports contain. Confidentiality is paramount to us.
Below, we expand beyond the top themes and go deeper on each area we actually saw in the reports. For each, you’ll find: what we observed, how often, representative examples (generalized to protect identity), and prescriptive actions you can take.