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 classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated (OAI) following an inspection in September 2025. The inspection, conducted by investigators Eileen A. Liu and Claudia Perez-Kasmarski, resulted in a Form 483 citing significant...
An USFDA 483 to CDMO major Catalent’s Baltimore facility (FEI 3015558590) in US cite poor aseptic practices and inadequate maintenance of the facilities. The site manufactures biological drug products, including Delandistrogene Moxeparvovec (Elevidys), and was inspected by FDA investigator Lizaida...
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...
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 classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated (OAI) following an inspection in September 2025. The inspection, conducted by investigators Eileen A. Liu and Claudia Perez-Kasmarski, resulted in a Form 483 citing significant...
An USFDA 483 to CDMO major Catalent’s Baltimore facility (FEI 3015558590) in US cite poor aseptic practices and inadequate maintenance of the facilities. The site manufactures biological drug products, including Delandistrogene Moxeparvovec (Elevidys), and was inspected by FDA investigator Lizaida...
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...
