Analysis Sees More Depth, Specificity in FDA Drug Inspections
A review of 42,192 observations from 8,663 inspections conducted between 2008 and 2026, as shown on the FDA inspection dashboard, found that 2026 does not represent a wholesale shift in FDA inspection priorities. Rather, according to regulatory consultant Jeffrey Palmer, writing in an online post, it reflects intensified scrutiny of established pharmaceutical quality system weaknesses.
Palmer lists these recurring themes:
- investigations that do not adequately determine root cause or scope;
- procedures that are missing, incomplete, unapproved, or not followed;
- quality units that lack sufficient authority or oversight;
- inadequate laboratory controls and incomplete raw data;
- weak cleaning, maintenance, and contamination-prevention systems
- insufficient supplier and component qualification;
- incomplete paper and electronic records; and
- CAPAs that address documentation without correcting the underlying system failure.
“For manufacturers,” Palmer writes, “this means inspection readiness cannot be limited to preparing documents or conducting a short-term mock inspection. Companies must be able to demonstrate that their systems work consistently in practice and that recurring issues are identified, investigated, corrected, and sustained over time.”
There are several other potentially newsworthy findings, including:
- Investigation-related deficiencies: 42.8% of 2026 inspections versus 38.5% in 2025.
- Sterile/contamination-control findings: 41.9% versus 31.4% in 2025 — a substantial increase.
- Finding on Facility/equipment/cleaning: 55.9% in 2026 versus 48.1% in 2025.
- Pharmacovigilance/postmarketing findings: 9.6% versus 3.9% in 2025.
- Meanwhile, the broadest systemic problem remains procedures/process controls: 77.7% of inspections had such a finding.
Palmer’s analysis gives several examples of each area of inspection concern seen in his analysis, with steps companies should take to address each area.