Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
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The USFDA has escalated the OAI (Official Action Indicated) classification of the Novo Nordisk–owned Catalent Indiana sterile drug products facility (FEI 3005949964) with a Warning letter. Earlier, the USFDA 483 issued after inspection of the Bloomington, Indiana site had cited...
FDA has published the USFDA Form 483 issued to sterile drug manufacturing facility of Fareva Amboise (FEI 3000234005) at Poce Sur Cisse in France. The site was inspected by FDA inspectors Vivin George, Justin A Boyd, Karen A Briggs from...
Biosimilarity CAA more sensitive than CES The USFDA has published a draft guidance updating scientific considerations for the use of comparative efficacy studies (CES) in demonstrating biosimilarity. The focus of the guidance is on therapeutic protein products. Building on experience...
We value your feedback on the Posts, Discussions, Information presented by Qvents. Also write to us on Pharma Quality and Regulatory topics and subjects you would like Qvents to cover. Your feedback helps us in making and maintaining the Qvents portal as a useful resource for Pharma TechOps professionals. Please also write to us for general feedback, quality of contents, any irrelevant or offensive posts, threads, comments
Please feel free to contact us for any enquiries.
Email: contact@qvents.in
Phone: (+91) 9945519525
We value your feedback on the Posts, Discussions, Information presented by Qvents. Also write to us on Pharma Quality and Regulatory topics and subjects you would like Qvents to cover. Your feedback helps us in making and maintaining the Qvents portal as a useful resource for Pharma TechOps professionals. Please also write to us for general feedback, quality of contents, any irrelevant or offensive posts, threads, comments
Please feel free to contact us for any enquiries.
Email: contact@qvents.in
Phone: (+91) 9945519525
The USFDA has escalated the OAI (Official Action Indicated) classification of the Novo Nordisk–owned Catalent Indiana sterile drug products facility (FEI 3005949964) with a Warning letter. Earlier, the USFDA 483 issued after inspection of the Bloomington, Indiana site had cited...
FDA has published the USFDA Form 483 issued to sterile drug manufacturing facility of Fareva Amboise (FEI 3000234005) at Poce Sur Cisse in France. The site was inspected by FDA inspectors Vivin George, Justin A Boyd, Karen A Briggs from...
Biosimilarity CAA more sensitive than CES The USFDA has published a draft guidance updating scientific considerations for the use of comparative efficacy studies (CES) in demonstrating biosimilarity. The focus of the guidance is on therapeutic protein products. Building on experience...
