Joanne Rupprecht, Esq., FRAPS, RAC, ACRP-CP, CCEP’s Post

Have you ever wondered about the likelihood of receiving a 483 Observation (aka finding/nonconformance) during an FDA Inspection? I recently came across this question and decided to dig into the data to find some hard facts. According to data from datadashboard.fda.gov (Inspections), the probability of receiving a 483 observation at the end of an FDA Inspection for Medical Device companies is approximately 50%. (higher or lower than you anticipated?) The reasons for receiving a 483 observation during an FDA Inspection can vary depending on the effectiveness of your people, processes, and systems. Typically, these observations can be categorized into two main areas: (1) inadequate translation of requirements into procedures and (2) lack of adequate evidence to demonstrate compliance with established procedures. Ensuring that you have qualified resources in place and fostering a strong quality culture within your facility can help promote compliance and reduce the chances of receiving 483 observations during FDA Inspections. Now, here's a question for you: How do your company's results compare to the industry average? #dataanalytics #fdainspection #483Observations

The receiving of a 483 does not directly correlate with noncompliance or nonconformity to regulations. What is on a 483 is an observation from the investigator. It can or cannot be a deviation from regulation. Yes supported by compliance review or not supported. Depending on the investigator experience and knowledge which can and does vary to the point of writing it on a 483 and that’s where it stays. If an error or non compliance supportable observation is written on a 483 Noice of observation rarely is there a retraction done by the agency unless there is a written follow-up which again rarely happens especially in a VAI classification on the particularly iffy item. . That said getting a 483 especially "low hanging” fruit is not that bad. At times getting a multi page with minor deviations given by a a-retentive soul because he/she likes to make a federal case out of everything and prefers the imortalization on the 483 vs. the EIR. In fact it is preferred over one single citation that is high risk regulatory and consumer high risk that can result in a Warning Letter plus recall etc. The approximate 50 percent chance is average in just getting a 483, again interpreted by issues that you have many investigators who do not like walking out of an inspection without issuing a 483 and many supervisory investigators who don’t like to see one of there own spend multiple days at a site and not "even issue” a 483. Bottom line not all 483s are created equal just like the creators.

Preparing for an FDA investigation can be a daunting experience for any medical device manufacturer. The stakes are high, and the consequences of non-compliance can be severe, including costly penalties and delays in bringing products to market. At DP Distribution & Consulting, we offer comprehensive pre-investigation services designed to help you navigate this critical phase with confidence. Our team conducts thorough assessments of your quality management systems and regulatory compliance, identifying potential issues before the official investigation takes place. By addressing these concerns proactively, we help you minimize risks and ensure that your business is fully prepared for the investigation process. Our goal is to help you achieve a successful outcome, maintaining your reputation for quality and compliance in the industry. Contact us today to learn more about our pre-investigation services and how we can support your business in meeting FDA requirements: https://bit.ly/3UotPwO #FDACompliance #QualityManagementSystems #MedicalDeviceStandards #DPDistributionConsulting #MedicalDevicesIndustry #FDAInvestigation #DeviceCertification #QualityManagement

The FDA audit is a pivotal step in the medical device regulatory journey. The gravity of this process cannot be overstated. Preparing for the audit is not just a wise choice but a necessity. Below, we have shared the key components of a Mock Audit, a crucial tool to ensure you are fully prepared for the regulatory audit. Here, we have a complete guide on Mock FDA Inspection Audit - https://lnkd.in/gwqFdcnn We hope this helps you. #medicaldevice #fda #regulatoryaudit #audits #medicaldeviceaudits #fdaaudit #mockaudit #mockfdaaudit #medicaldevicecompanies #medicaldevices #medicaldeviceregulatory #medicaldeviceregulation #inspections #regulatoryinspections

For my #medicaldevice friends, our MDSAP audit expert authored a helpful whitepaper you may be interested in: What to Expect During an FDA Inspection and How to Prepare. Please check it out and DM me if you have any questions. Have a great day! #MDSAP #audit #FDA

❓ Do you have a blind spot in your CAPA process? 👇 Here are 5 potential blind spots you should check (and fix): 1️⃣ Complaints, including reportable adverse events, are not considered for CAPA decision 2️⃣ Failing to conduct a health hazard evaluation (HHE) when required by CAPA procedure 3️⃣ Missing out on potential safety signals and not taking timely action through CAPA 4️⃣ Failing to escalate manufacturing nonconformances to CAPA for correction actions 5️⃣ Failing to check CAPA effectiveness and to ensure there no adverse effect on the medical device. 👇 Learn more about related FDA observations in these areas https://lnkd.in/ejKuh6S8 ===================================== 👍 Like this post? ♻ Share on your feed.

In the context of regulatory compliance and medical devices certification, a Notified Body assessment is not only a requirement but a crucial aspect of ensuring the safety and quality of medical devices. Whether it's during the conformity assessment process, audits, or post-market surveillance, these assessments may require additional information to be provided by the Manufacturers. These inquiries often demand meticulous responses that can significantly impact product approval timelines and market access. This webinar is tailored to provide insights and practical strategies for effectively addressing questions from Notified Bodies. 👇Click here to register: https://lnkd.in/dwn9GjRg

---FDA AUDIT--- US FDA, who inspect medical device manufacturers against the standards specified in FDA 21 CFR Part 820. There are four different types of inspections conducted by the FDA: ---Pre-Approval Inspections (PAIs): These inspections are conducted when a company applies to the FDA to market a new product. These inspections verify data included in the application, and confirm that the facility is capable of manufacturing the product. ---Routine Inspections: These inspections are a legal requirement every 2 years for class II and class III device manufacturers. They follow a method known as Quality System Inspection Technique (QSIT). If a serious public health risk is identified during this inspection, the inspection may become a “for cause” inspection. ---Compliance Follow-Up Inspections: This type of inspection reviews actions taken by a company following a previous inspection that resulted in significant 483 observations or a Warning Letter being issued. ---“For Cause” Inspections: This type of inspection investigate a specific problem that has been reported to FDA. The source of the report can be the manufacturer, consumer complaints, or even a disgruntled employee. #Fdaaudit #MedicalDeviceInsights

In the context of regulatory compliance and medical devices certification, a Notified Body assessment is not only a requirement but a crucial aspect of ensuring the safety and quality of medical devices. Whether it's during the conformity assessment process, audits, or post-market surveillance, these assessments may require additional information to be provided by the Manufacturers. These inquiries often demand meticulous responses that can significantly impact product approval timelines and market access. This webinar is tailored to provide insights and practical strategies for effectively addressing questions from Notified Bodies. 👇 Click here to register: https://lnkd.in/dwn9GjRg

News from Switzerland! The document has been released: "Information sheet - MDS requirements for corrective and preventive action plans". If deviations from the legal requirements are detected during a market surveillance activity by the authorities at an economic operator, Swissmedic requests a corrective action plan in writing to remedy these deviations. This information sheet is intended to support medical device business operators in the development of a CAPA plan and summarises the essential requirements at the content level. Source: https://lnkd.in/d5AHmJV4 #swissmedic #CAPA #plan #regulatoryaffairs #qualityassurance #vlfconsulting