AAMI releases TIR48 guidance for combination products

Manufacturers must review and evaluate all complaints to determine if an investigation is necessary. Investigations must be conducted for complaints involving possible failures to meet specifications, unless a similar complaint has already been investigated (21 CFR 820.198 & 21 CFR 211.198).   ➡ While written complaints have historically been prioritized and more scrutinized, oral complaints, received through customer service calls or informal conversations, are often not recorded or investigated as potential product quality complaints.  ➡ A medical device company received a 483 for failing to document oral complaints. The 483 reads:  Specifically, your firm’s SOP ,“Complaint Handling” procedure does not require oral complaints to be documented upon receipt and records of investigation to include a determination of whether the device failed to meet specifications, whether the device was being used for treatment or diagnosis, and the relationship, if any, of the device to the reported incident or adverse event. ➡ FDA’s position is clear: oral complaints are not informal communications to be disregarded—they are a critical part of the feedback loop for ensuring product quality and safety.  At PCGI, we assist our clients to ensure the complaint procedures include the evaluation of all complaints regardless of the form in which they are received. Contact me today. www.pharmacgi.com #complaints #CFR #oralcomplaints #FDA

🚨🚨 First UK Warning Letter from FDA of 2025 (I've seen!!) FDA has issued a warning letter to a UK-based manufacturer of RX series test systems following inspection violations discovered in August 2024. The letter identifies critical deficiencies in the firm's validation procedures and risk management, particularly regarding five Class II Recalls since 2018 related to reagent carryover issues in their analytical instruments, which led to erroneous test results. The manufacturer's corrective responses were deemed inadequate by the FDA, with concerns about incomplete risk analysis, unclear staff responsibilities, and insufficient corrective actions. The letter mandates a 15-day response period for the firm to outline specific remediation steps, including documentation of corrections and a timeline for implementation. The FDA emphasized that these violations could impact federal contract considerations and premarket approvals for Class III devices. #MedicalDevices #RegulatoryCompliance #FDA #QualityManagement https://lnkd.in/eUmhwMyq

Check out the hottest new YouTube channel for all things Good Manufacturing Practice and Aseptic Preparation of Sterile Medicines - Help Me GMP Help Me GMP will be dropping loads of guides, hints and tips from industry expert's to help you stay up to date and compliant. Check out our intro below https://lnkd.in/ehCwHcYH #pharma #manufacturing, #GMP #aseptics #GDP #cleanrooms #QMS #Annex1 #GoodManufactruingPractice GMP Help Me GMP | GMP, GDP, Pharma and Aseptic Training | GMP #GMP #GoodManufacturingPractice #GMPTraining #PharmaceuticalCompliance #AsepticProcessing #RegulatoryCompliance #QualityAssurance #PharmaManufacturing #PharmaCareers #AuditPreparation #QualityControl #PharmaceuticalRegulations #ComplianceTraining #HelpMeGMP #HelpMeGMPTraining

Follow the link bellow to read how RCA's regulatory compliance consultants approach investigating & reporting for biologics manufacturing vs. pharmaceuticals. https://ow.ly/tktP50Sc1g3

Aligning with GMP Annex 1 updates can be overwhelming—but it doesn’t have to be. From risk management to contamination control, ensuring compliance while maintaining efficiency is no small task. Falling behind these new guidelines isn’t just a regulatory risk—it could compromise product safety and quality. Ellab’s innovative solutions are designed to simplify Annex 1 compliance. Learn how we can help you lead in pharma safety. 👉 Read our blog now: https://lnkd.in/erqA2u_m

📣Join FDA and Parenteral Drug Association (PDA) on September 9-11 for the 33rd Joint Regulatory Conference to emphasize the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle. This conference is designed to share systemic and preventive approaches that are foundational to current good manufacturing practice (CGMP) compliance, and ensure effective ongoing management of manufacturing and supply chain risks. Register and learn more➡ https://lnkd.in/eyVQYdrK

📣Join FDA and Parenteral Drug Association (PDA) on September 9-11 for the 33rd Joint Regulatory Conference to emphasize the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle. This conference is designed to share systemic and preventive approaches that are foundational to current good manufacturing practice (CGMP) compliance, and ensure effective ongoing management of manufacturing and supply chain risks. Register and learn more➡ https://lnkd.in/eyVQYdrK

Are you 21 CFR Part 11 compliant? FDA audits can be a make-or-break moment for manufacturers in regulated industries. Non-compliance with 21 CFR Part 11 isn’t just a technical oversight—it can lead to warning letters, production stoppages, hefty fines, or even product recalls. Our latest blog dives into what happens when your operations fall short during an FDA audit and, more importantly, how to avoid it. Learn how robust access controls, audit trails, and system validation can protect your business while simplifying compliance. #FDACompliance #DataIntegrity #21CFRPart11 #RegulatoryAffairs #Phizzle

FDA has just released their guidance document for Laboratory Developed Tests (LDTs): Small Entity Compliance Guide. The shift in regulation marks a significant industry regulatory adjustment. Make sure to read through the details here: https://lnkd.in/ey65wX-m. 2Harris is here to assist with compliance. #FDA #LDTs #Compliance #Regulations

The FDA MoCRA GMP proposed rule is now scheduled for October 2025. 🔍 To learn more about this proposed rule, please click here: https://hubs.ly/Q030gZRD0 #MoCRA #MoCRAUpdate #FDA #QLaboratories