FiercePharma2 小时
FDA warning letter reveals quality control, data integrity issues at Viatris plant in India
In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...
FDA 510(K) Approved Facilities: Increasing GMP Inspections And Compliance Requirements
Indian medical device manufacturers are enhancing GMP compliance and embracing proactive strategies to meet rising USFDA ...
US FDA Inspection on Rise: Indian Pharma and Medical Devices Manufacturers Strengthen GMP ...
In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device ...
GlobalData on MSN4 天
FDA grants pre-market approval to HLB Life Science’s disposable syringe
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JD Supra17 天
I Don’t Want Your Photograph: Actually, FDA Might Want to Take Photographs During an ...
1 We have written in the past about companies’ refusal to allow, or make difficult, an FDA investigator’s ability to access certain records or files during an inspection. 2 It is not only a ...
Viatris’ Indore plant under U.S. FDA scanner, imports of certain products barred
The warning letter and the import alert followed an U.S. FDA inspection of the oral finished dose manufacturing facility in ...
Granules India focused on getting FDA nod for drug from Gagillapur by FY26
Hyderabad-based US-focused pharma firm Granules India expects the new drug applications from its Gagillapur facility in ...