Figure 1: All FDA-regulated categories as of January 2024
In summary, engaging an expert CAPA consultant or external party is a smart investment to reduce chances of the FDA issuing citations for a company’s quality system element, particularly under 21 CFR 820.100. The consultant’s specialized knowledge ensures a thorough examination and improvement of CAPA processes, addressing specific FDA concerns, and training staff. This proactive approach not only minimizes the risk of citations and legal consequences but also fosters a culture of continual improvement within the organization.
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FDA Inspections on the Rise
Consulting the FDA’s Case for Quality program
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“The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. The FDA’s analysis flagged certain widespread or common manufacturing risks that impact product quality. The review also showed manufacturers that focus on and manage those risks often become more productive, receiving fewer complaints, needing to open fewer corrective and preventive actions and investigations, and having lower quality-related product costs than their competitors.
As inspections rise, organization are divesting their traditional quality departments, leaving major gaps in production operations and increasing risks within the business. Some of those include inadequate product investigation and root cause analysis; effectiveness checks not performed (leading to warning letters); and possible legal ramifications, such as injunctions.
“The FDA is working with stakeholders—industry, healthcare providers, patients, payers, and investors—to build a strong Case for Quality program.
Figure 2: Device inspections for 2021, 2022, and 2023 as of January 2024
Figure 3: FDA citations by rank for medical devices as of January 2024
From a cost-effectiveness perspective, inviting a consultant’s intervention is a strategic move. Although upfront costs may be incurred, the long-term benefits far outweigh them. By preventing FDA citations, the company avoids potential fines, legal expenses, and operational disruptions. The improved efficiency in CAPA processes further contributes to overall productivity, customer satisfaction, and organizational reputation. In essence, investing in CAPA expertise isn’t just about compliance; it’s also a prudent strategy to safeguard the company’s financial health and uphold its commitment to quality and regulatory standards.
Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine.
The FDA inspects corrective and preventive actions (CAPA) within a company first because issues can be easily found within the organization’s issue management and CAPA process. According to current FDA data, companies’ biggest weaknesses tend to be CAPA inadequacies in procedures and a lack of proper documentation of executed processes.
Top 10 FDA citations in medical devices by inspected program area: 2021, 2022, and 2023
The rise has more than doubled within three years of post-pandemic inspections. Figure 1 shows foreign and domestic inspections for all FDA-regulated categories: tobacco, devices, biologics, drugs, food, cosmetics, and veterinary.
The FDA often approaches inspections using the quality system inspection technique (QSIT), in which four major areas of management control—CAPA, design controls, and production and process controls—are inspected. During subsequent routine inspections, inspectors will cover CAPA plus one additional subsystem. From the FDA data above, it can be deduced that: • There are organizational issues with CAPA management across the industry. • There are organizational issues with processing customer feedback and complaint handling. • Major procedural inadequacies are identified throughout key processes. • Interpretation of regulatory requirements is not applied adequately to standard operating procedures.
Organization gaps and solutions
Published: Wednesday, January 31, 2024 – 12:03
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“In simple terms, the review identified that an investment in quality has long-term payoffs.”
Even though the data lean toward increased inspections in 2024 for the medical device community, financial burdens on businesses have motivated organizations to divest in quality and cut quality departments first. Quality should always drive the business, and the quality department and function should be considered an investment instead of an expense, considering that this role leads and hosts FDA inspections and audits, mitigates risk to the business, and prioritizes continuous improvement.
“The Case for Quality program is intended to help the FDA identify device manufacturers that consistently produce high-quality devices. It will allow the FDA to identify participants with manufacturing practices that are of consistently high quality that also align with the laws and regulations implemented by the FDA. Finally, the program is designed to identify successful manufacturing practices to help other device manufacturers raise their manufacturing quality level.
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