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 Government of India has published a draft notification proposing an amendment to the Drugs Rules, 1945 (vide Gazette Notification G.S.R. 51(E), dated 21 January 2026). The amendment would require all antimicrobial drugs to display a conspicuous blue vertical strip...
The USFDA issued a Warning Letter to API manufacturer Chemspec Chemicals (Mumbai) in December 2025, following an inspection at its Navi Mumbai site (FEI 3004947391) in July 2025. FDA cited serious data integrity lapses and concluded that the firm’s quality systems...
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...
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 Government of India has published a draft notification proposing an amendment to the Drugs Rules, 1945 (vide Gazette Notification G.S.R. 51(E), dated 21 January 2026). The amendment would require all antimicrobial drugs to display a conspicuous blue vertical strip...
The USFDA issued a Warning Letter to API manufacturer Chemspec Chemicals (Mumbai) in December 2025, following an inspection at its Navi Mumbai site (FEI 3004947391) in July 2025. FDA cited serious data integrity lapses and concluded that the firm’s quality systems...
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...
