FDA OPQ Releases 2024 State of Pharmaceutical Quality Report: Key Trends for Pharma Professionals
August 19th, 2025 // 8:50 pm @ jmpickett
FDA’s Office of Pharmaceutical Quality (OPQ) has published its seventh annual State of Pharmaceutical Quality report for FY2024, providing an in-depth analysis of drug manufacturing oversight, inspection trends, and compliance patterns. Spanning October 2023 through September 2024, the report identifies emerging quality risks, evolving regulatory enforcement trends, and areas of potential concern for industry quality and regulatory affairs professionals.
High-level overview
FY2024 saw inspection volumes rebound strongly, with a marked increase in foreign site inspections, more warning letters, and continued growth in product approvals—including biosimilars. Overall quality performance remained solid, with 93% of sites achieving NAI or VAI, though risks were concentrated in API suppliers to compounding pharmacies, OTC manufacturers, and ophthalmic product lines.
Here are the key takeaways and implications for pharma QA/RA teams.
Inspection and Manufacturing Site Trends
- Total sites in CDER Site Catalog: 4,619 (41% U.S., 59% foreign)
- Inspections conducted in FY2024: 989 (+27% vs. FY2023)
- Foreign inspections: 62% of total (all-time high)
- MRA partner inspections: 198 (highest ever)
- Global compliance outcomes: 93% NAI/VAI; Europe led at 98%, India trailed at 87%
Insight: The significant rise in foreign inspections, particularly in India and China, underscores the FDA’s focus on global supply chain oversight. MRA partnerships are increasingly critical to extend surveillance capacity.
Product Portfolio Highlights
- Total products in CDER catalog:
- 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%)
- Overall product growth: +6.3%
Implication: Steady portfolio expansion highlights continued pressure on regulatory and quality teams to manage a growing and diverse drug landscape, particularly as biosimilars gain momentum.
Postmarket Quality Signals
- PQD reports: 16,837 (↓1.5%)
- MedWatch: 12,588 (+0.3%)
- Field Alert Reports (FARs): 3,515 (↓7.5%)
- BPDRs: 409 (+17%)
- Consumer complaints: 325 (↓18.3%)
Observation: While total PQDs declined slightly, the increase in BPDRs indicates ongoing challenges in biologics quality monitoring.
Import Alerts, Recalls, and Warning Letters
- Import alerts added: 75 (65% OTC, 25% API)
- Largest shares: China 39%, India 13%, Europe 13%
- Recalls: 421 (lowest in five years)
- Most common defects: microbial contamination (31%), sterility (28%), particulates (20%)
- Top product categories: Ophthalmic (14.1%), Antibacterials, Cardiovascular, Dermatological
- Warning letters: 105 issued (5-year high)
- Domestic: 41 (↓ from 59)
- Foreign: 64 (↑), driven by inspection activity
- Notably, 72% of warning letters against API suppliers were tied to sites supporting compounding pharmacies (only 18% of total API sites)
Takeaway: Enforcement actions are increasingly concentrated on high-risk segments, particularly API suppliers for compounding, and underscore the importance of proactive quality management and supply chain oversight.
API Supply Chain Concerns
A standout finding: API sites serving compounding pharmacies continue to exhibit disproportionate quality challenges. Despite representing just 18% of all API manufacturers, these sites accounted for 72% of regulatory actions, primarily located in China (51%) and India (30%).
Implication: Quality professionals in compounding and API procurement should prioritize auditing, QMS strengthening, and inspection readiness. The trend aligns with a notable uptick in sites proactively engaging with RA/QA consultants to address gaps.
Import Alerts Signal Broader Surveillance
The FDA issued import alerts to 75 sites, with 40% targeting facilities never previously inspected. OTC monograph drug manufacturers accounted for the majority (65%), while API manufacturers made up 25%. The use of Section 704(a)(4) records requests allowed the FDA to extend oversight beyond traditional inspections.
Drug Amount Reporting: Progress and Gaps
- Compliance for application products (CY2024): BLAs 71%, NDAs 65%, ANDAs 60%
- OTC monograph products: Only 37% compliant
Implication: Incomplete reporting may increasingly influence inspection targeting and risk prioritization, emphasizing the need for accurate, timely data submission.
Bottom line for pharma QA/RA teams:
FY2024 reinforces that inspection intensity, foreign site oversight, and supply chain risk management remain at the forefront. Regulatory strategies must account for rising enforcement, targeted oversight of high-risk segments, and the ongoing expansion of product portfolios, particularly biosimilars and compounding APIs.
