☧ Life Science Industry Champion | Get FDA Ready! | Quality System Remediation Planning & Execution | QA Staff Augmentation ☧
FDA: 2023 Compliance Trends & Plans for 2024... Officials from the drug, biologics and medtech inspection offices said failure to maintain good manufacturing practices (GMPs) are still among the main reasons for issuing warning letters. “Corrective and Preventive Actions (CAPAs) always remain at the top in the device space [for OAI inspections]. Complaint handling is number two, medical device reporting is third, process validation is fourth, and rounding that out is design changes. There is a large percentage of OAIs that also include unapproved device charges.” For drugs, about 46% of the warning letters were for current good manufacturing practice (CGMP) violations. You can expect FDA to be more active in 2024. How are your GMPs? Are you FDA Ready? We can help. Contact us today to find out how: https://lnkd.in/eFVUfDm #fda #GMP #qualityassurance https://lnkd.in/gqCceZtS
