Compliance Insight, Inc.

Data integrity issues resurface with FDA findings regarding Mid-Link Technology Testing Co., Ltd. The FDA uncovered instances where study results were copied or data was falsified, leading to the rejection of all study data from this facility until the concerns are resolved. Surprisingly, company executives were unaware of these questionable practices. It's a stark reminder of the adage, "you don't know what you don't know." The crucial query remains: are proactive measures being taken to uncover unknown issues? Contact your trusted advisors at Compliance Insight to get insight into your compliance. Email: [email protected] Web: www.compliance-insight.com Phone: 513-860-3512

FDA Observation snip-its What do all of these companies have in common? 1 – they received serious FDA observations that lead to further regulatory actions 2 – executives did not know these problems existed While many observations address common compliance issues, some stand out due to their unusual or concerning nature. Here are a few notable examples: 1. Document Shredding and Misleading Investigators FDA inspectors observed employees shredding documents during an inspection. Additionally, live-feed cameras showed production staff hurriedly signing and passing documents among themselves. When inspectors requested to visit the production area, they were deliberately directed to incorrect locations, hindering the inspection process. 2. Lack of Sample Traceability An FDA 483 highlighted that after samples were received in Quality Control (QC), their movement between different labs for various tests couldn't be traced. This lack of sample traceability poses significant risks to data integrity and product quality. 3. Inadequate Chain of Custody Procedures In another instance, a company failed to maintain proper chain of custody for samples moving between different QC labs. This deficiency was noted in multiple inspections and had not been corrected. These examples highlight the critical need for a “second opinion”.?To examine the functioning body of the company to check for any anomalies that may be a GMP cancer growing undetected.? Contact your trusted advisors at Compliance Insight to schedule an examination of your operations.?? Email:?[email protected]? Phone:?513-860-3512 Web:?www.compliance-insight.com?

FDA 483 Snip-it: Observed operators in the aseptic zone wipe their hands with IPA prior to performing hand plate sampling. Response: we will retrain them on the importance of the sampling. What do you think? Appropriate? Will the FDA be satisfied with the response? FDA 483 Response Services by Compliance Insight Ensure Compliance. Protect Your Business. Receiving an FDA Form 483 can be overwhelming, but with Compliance Insight, you have a trusted partner to guide you through the response process with confidence and expertise. Our FDA 483 Response Team helps you address observations effectively, mitigate risks, and demonstrate your commitment to compliance. Why Choose Compliance Insight? Industry Experts: Each member of our team has decades of experience in FDA regulations across pharmaceuticals, biotechnology, medical devices, and other regulated industries. Proven Track Record: We have successfully assisted companies in crafting compliant responses that satisfy FDA expectations. Customized Solutions: Every response is tailored to your specific situation, ensuring a strategic and effective resolution. Our FDA 483 Response Process Comprehensive Review – We analyze the FDA 483 observations to identify root causes and potential compliance risks. Strategic Response Development – Our experts craft a well-structured, detailed response addressing each observation with corrective and preventive actions (CAPA) to a holistic resolution. Regulatory Guidance & Support – We ensure your response aligns with FDA expectations and industry best practices. Implementation Assistance – Our team provides guidance in executing corrective actions to ensure short-term mitigation and long-term compliance. Follow-Up & Readiness – We help you prepare for future FDA interactions, reducing the risk of further regulatory action. Act Now – Time is Critical! The FDA expects a response within 15 business days of receiving a Form 483. Delays or inadequate responses can lead to further enforcement actions, including Warning Letters or product recalls. Let Compliance Insight Help You Stay Ahead of Compliance Challenges! Contact Us Today to discuss your FDA 483 response strategy. Website: www.compliance-insight.com Email: [email protected] Phone: 513-860-3512

This may sound worse than it is, but attached is one of the first public rulings made by new HHS Secretary, Robert F. Kennedy, Jr.. Secretary Kennedy is rescinding the "Richardson Waiver" from 1971, which required public notice and comment periods for rules and regulations related to "agency management, personnel, public property, loans, grants, benefits, or contracts" even though the Administrative Procedure Act (APA) allowed such rules to be exempt from public notice and comment periods. HHS, which includes the FDA, will no longer provide a notice and comment period for rules or regulations on these topics. Of more concern to me is that the Richardson Waiver mandated that the Department use "sparingly" an APA provision that also allowed executive departments to avoid a public notice and comment period for rules, where the department felt that public notice and comment periods were "impracticable, unnecessary, or contrary to the public interest." This policy statement from Secretary Kennedy makes clear that HHS will no longer use this "good cause" exemption "sparingly," which may increase the number of rules and regulations, which will be published as final with no public notice or comment period.

FDA Warning Letter snippet: Facility has areas not maintained and in a state of decay. QMR identified significant gaps in training which were not addressed effectively. Sterile operations were not maintained with basic requirements being ignored and willfully violated. What can you do about these issues: The GxP compliance process of Align, Apply, and Adapt is a structured approach to ensuring that GxP standards are effectively integrated into an organization’s operations. Here’s how this framework works: 1. ALIGN – Establishing Compliance Foundations This phase ensures that the company’s policies, procedures, and systems are aligned with regulatory expectations and industry best practices. Key Activities: ? Regulatory Landscape Assessment – Identify applicable FDA guidelines. ? Gap Analysis – Assess current systems against regulatory requirements and industry benchmarks. ? Quality & Compliance Framework Development – Establish or refine SOPs, policies, and quality systems. ? Stakeholder Buy-In – Ensure leadership and teams understand compliance priorities and objectives. ?? Outcome: A clear compliance roadmap that aligns business operations with regulatory expectations. 2. APPLY – Implementation & Execution Focuses on applying compliance principles into daily operations to ensure processes are followed consistently and effectively. Key Activities: ? Training & Competency Development – Conduct role-specific GMP training for employees. ? Process Integration – Embed compliance into manufacturing, quality control, and clinical operations. ? Data Integrity & Documentation – Ensure ALCOA+ principles are met. ? Routine Monitoring & Self-Inspections – Conduct internal audits and quality reviews to identify gaps before regulatory inspections. ?? Outcome: Compliance becomes part of the company’s operational culture, not just a checkbox activity. 3. ADAPT – Continuous Improvement & Risk Management Since regulations and business environments evolve, organizations must continuously adapt their compliance approach to remain inspection-ready and competitive. Key Activities: ? Regulatory Change Management – Monitor FDA updates and enhance policies accordingly. ? Process Optimization – Leverage insights from deviations, CAPAs, and audit findings to improve compliance efficiency. ? Technology & Automation – Implement digital compliance tools to enhance data integrity and reduce human error. ? Culture of Compliance – Foster a mindset where compliance is proactive rather than reactive. ?? Outcome: A resilient, future-proof compliance program that evolves with regulatory changes and business needs. Why This Approach Matters ?? Prevents last-minute compliance scrambles before inspections. ?? Reduces regulatory risk and ensures inspection readiness at all times. ?? Increases operational efficiency by integrating compliance into day-to-day processes. ?? Supports scalability, ensuring compliance remains strong as the company grows.