Inspections
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Breaking News | Facilities | Industry News | Inspections
PharmaCyte Conducts Final Audit of Mfg. Facility
Batch records in Thailand have been deemed cGMP compliantContract Pharma Staff 05.18.20
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cGMP Manufacture | GMPs/GCPs | Inspections | Regulatory Affairs
FDA cGMP Inspections Amid COVID-19 Pandemic
Despite FDA's postponement of most facility inspections, the pharma manufacturing industry should be prepared for heightened scrutiny as this crisis develops.John J. Carney, Lee H. Rosebush, Susrut A. Carpenter, Andrew M. Serrao, BakerHostetler 04.22.20
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Bio News | Breaking News | Industry News | Inspections
WuXi Biologics Passes EMA GMP Inspection
Suzhou site clears regulatory hurdle with not critical findingsContract Pharma Staff 04.15.20
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Breaking News | Industry News | Inspections | Regulatory Affairs
COVID-19 Update: FDA Scales Back Domestic Inspections
Temporarily postpones all domestic routine surveillance facility inspections, for-cause inspections will be evaluated and will proceed if mission-critical.03.19.20
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Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs
COVID-19 Update: FDA Foreign Inspections
To postpone most foreign inspections through April, effective immediately03.10.20
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Breaking News | Industry News | Inspections
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Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs
FDA Provides Update on Activities Related to Coronavirus
Says it continues to monitor the global drug supply chain by prioritizing risk-based inspections in other parts of the world02.25.20
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Breaking News | Industry News | Inspections
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Breaking News | Industry News | Inspections
LSNE-León Successfully Completes PAI
Can now support commercial manufacturing of a sterile injectable product in a pre-filled syringe presentation01.21.20
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Breaking News | Facilities | Industry News | Inspections
Metrics Completes Japanese Regulatory Inspection
Marks the first international inspection of the company’s new 126,000-square-foot commercial manufacturing facility constructed in 2018.11.18.19
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Breaking News | Facilities | Industry News | Inspections
WuXi STA’s Jinshan Facility Passes EMA Inspection
Five-day inspection covered 11 products approved by EMA in recent years.10.28.19
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Breaking News | GMPs/GCPs | Industry News | Inspections
ASIT biotech Receives GMP Certification
Site in Liège, Belgium to manufacture in-house the active pharmaceutical ingredient of its leading product for grass pollen allergies10.07.19
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Breaking News | Industry News | Inspections | Regulatory Affairs
Almac Completes Three Regulatory Inspections
Inspections at Charnwood, Craigavon, and Audubon sites successful09.27.19
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Bio News | Breaking News | Industry News | Inspections
3P Biopharmaceuticals Receives FDA approval
FDA classified 3P facilities as acceptable for manufacture of target molecule, and appropriate for commercialization in the US once product is authorized09.18.19
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Breaking News | Clinical Trials | Industry News | Inspections | QA/QC
FDA Extends CRADA with CluePoints
Aims to further explore a data-driven approach to quality oversight in clinical trials09.11.19
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Breaking News | Industry News | Inspections
Bora Secures FDA Approval for CDMO Services
Reports successful inspection of Zhunan, Taiwan site09.03.19
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APIs | Breaking News | Facilities | Industry News | Inspections
Carbogen Amcis API Site Passes FDA PAI
Completes successful FDA inspection of its Neuland site in Hunzenschwil, Switzerland with no Form 483s08.07.19
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Industry News | Inspections | Regulatory Affairs
WuXi STA Facilities Pass U.S. FDA Inspections
Analytical Service Unit in Shanghai and API manufacturing facility in Changzhou successfully pass inspections07.24.19
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Breaking News | Industry News | Inspections
WuXi STA Facilities Pass FDA Inspections
No Form 483s were issued at Shanghai and Changzhou sites07.23.19
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Bio News | Breaking News | cGMP Manufacture | Facilities | Industry News | Inspections
Cytovance Completes Second FDA PAI of Oklahoma Facilities
Demonstrates capabilities and cGMP compliance in manufacturing commercial products06.18.19
