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Check out this article diving into insights from the FDA's enforcement actions in FY23! The FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023, with 94 stemming from on-site inspections. Discover the nuances of the FDA's enforcement approach and insights from these inspection-based letters. Read more to stay informed. #FDA #BiopharmaInsights #RegulatoryCompliance #fdainspections #regulatoryinspections  #regulatorycompliance #drugmanufacturing #SymmetricTraining

🔍💊 In fiscal year 2023, the U.S. FDA took a proactive stance towards drug and biologics manufacturers, issuing 180 warning letters—a notable uptick from the previous fiscal year. This surge, particularly in inspection-based warnings, reflects a potential return to pre-pandemic operational norms - which is certainly what we need. 52% of these letters stemmed from on-site inspections, indicating a thorough regulatory oversight. Delving deeper into these trends offers valuable insights into the FDA's enforcement strategies and underscores the importance of compliance within the pharmaceutical industry. Similar to the 18 letters issued in FY22, FDA underscored the responsibilities of both the contract manufacturer(s) and the product sponsor in 19 letters in FY23. #FDA #RegulatoryCompliance #PharmaceuticalIndustry #FY23

Approximately 180 FDA warning letters were sent out in 2023. Explore some of the trends that prompted this action in Pharmaceutical Online’s recent article. Received an FDA warning letter? FDAQRC’s Remediation services are here to help get your projects on the right track! Read more here: https://lnkd.in/dM_Fis7Q #FDAnews #regulatorycompliance #qualityassurance #industrynews #FDAwarningletter #remediation #continuousimprovement

Trends In FDA FY2023 Inspection-Based Warning Letters The USFDA issued 180 warning letters to drug and biologics manufacturers in FY2023. Of those letters, 94 were based on an on-site inspection of the company, 27 were the result of records requests sent under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 6 stemmed from testing product samples, and the remainder were generally based on review of product labels, registration materials, and/or websites. This is compared to the 165 drug and biological product warning letters issued in FY22, 74 of which were based on inspections. The uptick in the total number of warning letters, as well as the increase in the percentage of inspection-based warning letters (52% in FY23 compared to 45% in FY22) could be the result of a full return to normal inspectional operations after the COVID-19 pandemic. This article provides an analysis of trends and observations from the FY23 inspection-based letters, as well as additional insight on the agency’s approach to enforcement. Source Link: https://lnkd.in/dC7gUuBP

Trends In FDA FY2023 Inspection-Based Warning Letters The USFDA issued 180 warning letters to drug and biologics manufacturers in FY2023. Of those letters, 94 were based on an on-site inspection of the company, 27 were the result of records requests sent under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 6 stemmed from testing product samples, and the remainder were generally based on review of product labels, registration materials, and/or websites. This is compared to the 165 drug and biological product warning letters issued in FY22, 74 of which were based on inspections. The uptick in the total number of warning letters, as well as the increase in the percentage of inspection-based warning letters (52% in FY23 compared to 45% in FY22) could be the result of a full return to normal inspectional operations after the COVID-19 pandemic. This article provides an analysis of trends and observations from the FY23 inspection-based letters, as well as additional insight on the agency’s approach to enforcement. Source Link: https://lnkd.in/dgfD8fFD

The FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. In this new article, Elizabeth Oestreich, Kalah Auchincloss, and Madeleine Giaquinto of Greenleaf Health, Inc. provide an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement. https://lnkd.in/eijcaruX #regulatory #regulatoryinspections #fdainspections #regulatorycompliance #drugmanufacturing

#nitrosamines are potentially harmful impurities that can be found in certain medications and products. Products that have been found to contain #nitrosamines impurities include certain blood pressure medications like valsartan, losartan, and irbesartan, as well as ranitidine, a medication used to treat heartburn and ulcers. The #usfda has issued guidelines for the testing and control of nitrosamine impurities in various pharmaceutical products to ensure their safety. These guidelines aim to minimize the presence of nitrosamines, which are known to have carcinogenic properties. Pharmaceutical companies are expected to conduct rigorous testing to detect and quantify nitrosamine impurities and take appropriate measures to mitigate their presence if detected. The guidelines are part of the FDA's broader efforts to ensure the safety of drugs and related products. Auriga Research Laboratories is a USFDA approved faciliy to ensure your products are tested under stringent protocols for "free from Nitrosamine Impurities" Auriga's objective is to provide accurate and insightful results, with a prerogative approach to meet regulatory compliance. Contact or mail to Chetan Kulkarni chetan.kulkarni@aurigaresearch.com 9701703704 / 8105759208 #nitrosamines #drugimpurities, Auriga Research Private Ltd. Arbro Pharmaceuticals Private Ltd.

The FDA sent 180 warning letters to manufacturers in 2023. Failure to follow cGMP guidelines was cited more than any other issue, tied with failure to establish sufficient written procedures. At LSPedia, we offer a Gap analysis of SOP documents for manufacturers to assure proper adherence to #DSCSA compliance. https://hubs.la/Q02kS_j20 #pharmamanufacturers #onescan #traceability #serialization #FDA #pharma #pharmaceuticals

Be curious about the latest Warning Letter trends! As the regulatory landscape continues to evolve, it's crucial for professionals in the pharmaceutical, biotech, and medical device industries to stay informed. Understanding the trends highlighted in the linked article can help your organization strengthen your quality systems and ensure regulatory compliance. Join the conversation in the comments section to delve into key insights and implications for our industry. Stay ahead of the curve and navigate regulatory complexities with confidence! #FDA #Compliance #RegulatoryTrends #Pharma #Biotech #MedicalDevices"

The recent alert from CDSCO, highlighting over 50 drugs as not meeting quality standards, serves as a wake-up call for everyone in the pharmaceutical industry. The presence of substandard and potentially counterfeit drugs in the market is not just alarming; it threatens the very foundation of trust between healthcare providers and patients. This issue extends beyond compliance and regulations. The issue of counterfeit drugs touches on the integrity of healthcare itself. Behind every pill is a person. Behind every pill is a patient who relies on us to provide safe, effective treatments. It's not just about regulatory compliance, but about the trust that individuals place in us for their health and well-being. Let this challenge drive us to strengthen our processes, innovate in quality assurance, and above all, protect the trust that patients have in our care. https://lnkd.in/gMxmni9h #healthcare #DrugsAndMedicine #Affordablehealthcare