FDA OPQ FY2024 State of Pharmaceutical Quality: Executive Highlights
August 19th, 2025 // 8:48 pm @ jmpickett
Inspection & Compliance Trends
- Inspections: 989 total (+27% vs FY2023), with 62% foreign (all-time high)
- MRA partner inspections: 198 (highest ever)
- Compliance: 93% of sites NAI/VAI; Europe led (98%), India lowest (87%)
Key Takeaway: Foreign oversight is surging—particularly India and China—while global compliance remains strong but uneven.
Product Portfolio Growth
- ANDAs: 14,168 (+4.4%)
- NDAs: 3,625 (+0.9%)
- BLAs: 383 (+8.2%), including 63 biosimilars (+47%)
- Non-application NDCs: 140,119 (+6.7%)
Key Takeaway: Expansion, especially in biosimilars, is increasing regulatory and quality management demands.
Postmarket Quality Signals
- PQDs: 16,837 (↓1.5%)
- BPDRs: 409 (+17%)
- FARs: 3,515 (↓7.5%)
Key Takeaway: Biologics deviations rising; continued vigilance needed for high-risk product lines.
Enforcement & Import Alerts
- Warning letters: 105 issued (5-year high)
- Domestic: 41, Foreign: 64 (inspection-driven)
- API suppliers to compounding pharmacies: 72% of actions, though only 18% of sites
- Import alerts: 75 sites added; 40% never inspected before
- Recalls: 421 (lowest in 5 years); top defect = contamination (microbial 31%, sterility 28%)
Key Takeaway: Enforcement is concentrated on high-risk supply chains, particularly compounding APIs, OTC monograph products, and ophthalmics.
Data & Reporting Insights
- Drug amount reporting improved for application products (BLAs 71%, NDAs 65%, ANDAs 60%)
- OTC monograph compliance lags at 37%
- Incomplete reporting may increasingly drive inspection targeting
Strategic Implications for QA/RA Leaders
- Prioritize high-risk suppliers: Focus on API providers for compounding and foreign manufacturing sites.
- Strengthen QMS and inspection readiness: Proactive audits reduce risk of 483s or warning letters.
- Leverage regulatory intelligence: Monitor FDA enforcement trends and 704(a)(4) records requests for strategic oversight.
- Data-driven surveillance: Ensure accurate product reporting; gaps may trigger targeted inspections.
Bottom line: FY2024 signals heightened global oversight, targeted enforcement, and supply chain focus. QA/RA teams must balance compliance, proactive risk mitigation, and portfolio growth management to stay ahead.
