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Analysis of the Regulatory Inspection Trends of China, the U.S. and the EU in the Pandemic Year and Outlook Therefor PharmaSources/zhulikou431
February 08, 2021
International GMP compliance inspections in the pharmaceutical industry decreased significantly in 2020 as affected by the COVID-19 pandemic.
The conundrum of USFDA inspections expresspharma
July 29, 2020
Alok Ghosh, Ex-President - Global Technical Services, Lupin, shares insights on the challenges that India Pharma Inc faces with US FDA inspections and talks about measures that can help improve compliance and ...
US FDA working to restart on-site inspections during week of July 20 expresspharma
July 17, 2020
The FDA, which is working towards resuming on-site inspections around July 20, also determined that, for the foreseeable future, prioritized domestic inspections will be pre-announced to FDA-regulated businesses.
US FDA postpones foreign inspections over coronavirus outbreak expresspharma
March 12, 2020
According to Stephen M Hahn, Commissioner of Food and Drugs – Food and Drug Administration, the foreign inspections will resume as soon as feasible.
COVID-19 Update: FDA Foreign Inspections contractpharma
March 11, 2020
To postpone most foreign inspections through April, effective immediately.
FDA issues warning letter which highlights the importance of a quality unit europeanpharmaceuticalreview
January 07, 2020
Henan Kangdi Medical Devices Co Ltd has been sent a warner letter after an inspection found cGMP violations that included failures of the company’s quality unit.
EMA announces launch of collaborative pilot scheme to inspect manufacturers europeanpharmaceuticalreview
January 03, 2020
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
Strides completes US FDA inspection at its Alathur facility expresspharma
August 15, 2019
Strides Pharma Science recently announced that its formulation facility at Alathur, Chennai, India underwent a US FDA inspection starting August 05, 2019 and the inspection concluded with “Zero 483 observations”.
Novartis inspection puts into question who knew what—and when—about Zolgensma data manipulation fiercepharma
August 14, 2019
Novartis, which last week was publicly shamed by the FDA for manipulating data tied to the application of its gene therapy Zolgensma, has said that it launched an investigation in March, as soon as it learned of the issue.
WuXi STA Facilities Pass U.S. FDA Inspections contractpharma
July 25, 2019
Analytical Service Unit in Shanghai and API manufacturing facility in Changzhou successfully pass inspections.

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