7 Key Takeaways From FDA's FY2023 Report on the State of Pharmaceutical Quality
We dissect and analyze the FDA's latest pharma quality report.
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The FDA’s Fiscal Year 2023 Report on the State of Pharmaceutical Quality offers vital insights that RA/QA teams in the pharmaceutical industry should pay close attention to. As we navigate an increasingly complex regulatory landscape, these key takeaways highlight critical focus areas and underscore the importance of proactive quality management.
Here are the top-line facts included in the report:
There are 4,819 manufacturing sites globally that the FDA oversees (referred to as the “Site Catalog”). About 42% of these sites are in the U.S., representing a 14% increase over the past five years.
Of the 4,819 sites, 40% are in the “no applications sector” (producing either OTC monograph products, homeopathic drugs, or marketing new drugs not approved by the FDA).
The FDA conducted 776 drug quality assurance inspections, over 40% more than the 548 accomplished in FY2022.
The top five countries with manufacturing facilities supplying the U.S. market are the U.S. (2,009), India (585), China (484), Germany (195), and Italy (151). An interesting chart in the report illustrates the growth in the number of facilities by country over the five-year period from FY 2019 to FY 2023. Notably, only Canada and the UK have seen a decrease in the number of sites (4% and 1%, respectively) over the past five years.
Inspections classified under Mutual Recognition Agreements (MRAs) increased from 144 in FY2022 to 187 in FY2023, the highest number to date. This demonstrates an increased reliance on foreign inspectorates, reducing redundant inspectional work and allowing more efficient use of limited Agency resources. It also benefits the industry by minimizing repetitive inspections by different regulatory authorities.
In 2023, 25% of the India facilities in the site catalog were inspected, while only 6% of the facilities in China were inspected. The OPQ indicates that higher inspectional coverage in India was driven by for-cause inspections, while travel restrictions in China delayed inspections.
At the end of FY2023, CDER’s Product Catalog contained 17,519 application products (16,698 in FY2022) and 131,367 non-application product National Drug Codes (123,532 in FY2022). This large number of products and SKUs necessitates extensive quality metrics evaluations, keeping the OPQ and the inspectorate busy.
During FY2023, CDER received 12,549 quality-related MedWatch reports (a 1.6% increase from FY2022), 3,792 Field Alert Reports (an 8.3% increase from FY2022), 347 Biological Product Deviation Reports (a 77% increase from FY2022), and 398 quality-related Consumer Complaints (a 53.7% increase from FY2022). The report details reasons for these increases, including specific product events such as recalls of ophthalmic products that experienced quality issues.
There were more drug quality-related import alert additions in FY2023 (93) than during FY2021 and FY2022 combined (77). This increase was partially associated with hand sanitizer manufacturing issues.
In FY2023, there were 674 drug products recalled, down 26% from the high of 912 in FY2022. The FY2023 recalls involved 158 sites that generated 225 recall events. Notably, 35% of recalled products were associated with five specific events outlined in the report.
In FY2023, the FDA issued 94 warning letters to drug manufacturing sites for reasons related to drug quality.
Here’s our breakdown of the report’s findings and the strategic advice necessary to improve quality assurance practices.
1. More global manufacturing sites and more inspections
The FDA ramped up its drug quality assurance inspections significantly, jumping from 548 inspections in FY2022 to 776 in FY2023.
The CDER Site Catalog now includes 4,819 drug manufacturing sites globally, with nearly 42% located in the U.S. More inspections clearly signal heightened regulatory scrutiny — not surprising given the pressure the agency has received to conduct more inspections and work through its massive pandemic backlog.
Why this matters: This one should be obvious — more inspections mean more pressure to be perpetually inspection-ready. We’re still seeing firms operate like the FDA hasn’t ramped up its inspection program. They have, and this data finally proves what we’ve observed for over a year now. If you are not ready for the FDA to walk through your doors, talk to us to schedule an audit and/or mock inspection led by former FDA professionals.
Our advice:
Schedule bi-monthly reviews of all compliance protocols. Your documentation, procedures, and training materials should all be current.
Conduct internal audits quarterly. Develop a comprehensive audit checklist covering all aspects of manufacturing, from raw material sourcing to final product testing. Use these audits to identify and rectify potential compliance issues proactively.
Implement mandatory training sessions for staff focused on FDA inspection readiness. Training should cover what to expect during an inspection, how to interact with inspectors, and how to ensure all procedures are followed meticulously. (We often integrate training as a component of our mock inspection services.)
Organize bi-annual mock inspections with third-party consultants to simulate actual FDA inspections. This can help identify gaps and areas needing improvement. Again, contact us if you’re due for a mock inspection.
2. More MRAs and foreign inspections
FY2023 saw the highest number of MRA partner inspections to date, with 187 inspections conducted.
Foreign inspections, constituting approximately 59% of all drug quality assurance inspections, have also increased. The FDA is clearly focusing on global supply chain integrity, underscoring the importance of maintaining high standards and compliance assurance across all manufacturing sites, regardless of location.
Why this matters: MRAs and foreign inspections are two of the FDA’s critical tools in ensuring that drugs manufactured abroad meet U.S. quality standards. Maintaining total control over these supply chains has gotten more complex as pharma supply chains continue to globalize. If you rely on suppliers for which you’re responsible, when was the last time you audited them?
Our advice:
If you haven’t conducted robust supplier audits in a while, get them on the calendar as soon as possible. In 2024, we’ve seen more demand for supplier auditing services than ever before — a clear reflection of how supply chains continue to fan out worldwide. Read our guide to supplier audits for best practices and get in touch to talk about scheduling out your supplier audits this year. (Many firms frustrated with too many audit vendors typically bundle their audits through us for a deep discount. More on that here.)
Establish and/or review your detailed quality agreements with all foreign manufacturing partners. These agreements should outline specific quality standards, documentation requirements, and inspection protocols. Talk to us if you need expert help writing one that’s air-tight.
If possible, use collaborative technology platforms to maintain real-time communication and document sharing with international partners. This helps ensure transparency and quick resolution of any quality issues. Microsoft Teams offers end-to-end encryption, multi-factor authentication, compliance with HIPAA, GDPR, and other regulatory standards, data loss prevention, and secure access controls. Google Workspace (formerly G Suite) is another option. It offers advanced phishing and malware protection, encryption in transit and at rest, security key enforcement, context-aware access, and compliance with HIPAA, GDPR, and other regulations.
3. The Quality Management Maturity (QMM) program is progressing
The QMM program is designed to foster a quality culture mindset among pharmaceutical manufacturers. It encourages proactive quality management practices to improve product quality and regulatory compliance.
The FDA has developed a prototype assessment protocol for evaluating the quality management maturity of manufacturing sites. This protocol, described in an August 2023 white paper, aims to provide a structured approach to assessing and improving quality management practices.
Throughout 2023, the FDA engaged with over ten stakeholder groups through facilitated discussions to gather input and perspectives on the QMM program. Additionally, a public docket was established to receive responses about the voluntary QMM program, which received 23 submissions.
In January 2024, the FDA announced a voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program. This program invites a limited group of manufacturers to participate in the assessment and provide feedback on the protocol. The goal: refine the assessment process based on real-world applications.