Inspections
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Breaking News | Industry News | Inspections
CordenPharma Latina US-FDA Warning Letter Closed
Closeout date was August 15 for the Italy facility08.24.17
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Industry News | Inspections
Valeant's Tampa Facility Receives FDA VAI Classification
Following collaboration with FDA, issues related to a cGMP inspection are being resolved08.17.17
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Breaking News | Facilities | Industry News | Inspections
Aerie Pharma’s CMO Receives FDA CRL
Was issued in response to CGMP inspection at Tampa facility08.10.17
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Industry News | Inspections
Envigo Site Recertified to New ISO Standard
ISO9001:2015 revision has re-focused on performance by combining the process approach with risk-based thinking07.28.17
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Industry News | Inspections
Cytovance Completes FDA Inspection at Oklahoma City Facilities
Takes action to address facility updates and improvements07.24.17
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cGMP Manufacture | Industry News | Inspections
QS Pharma Gains EMA Approval for Commercial Manufacture
Boothwyn, PA facility to manufacture certain medicinal products for commercial use in Europe06.27.17
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Breaking News | Industry News | Inspections
Tapemark Passes Regulatory Hurdle
Manufacturing facility completes successful FDA pre-approval and general GMP inspection06.07.17
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Inspections | Regulatory Affairs
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Breaking News | Industry News | Inspections
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cGMP Manufacture | Industry News | Inspections | Regulatory Affairs
Protalix Wins FDA Approval as Multi-Product Facility
To support the potential manufacture of pegunigalsidase alfa and taliglucerase alfa on a commercial scale06.01.17
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Breaking News | Facilities | Industry News | Inspections
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Aseptic Processing | Bio News | Breaking News | Facilities | Fill/Finish | Industry News | Inspections | Lyophilization
LSNE Completes Two FDA Inspections
FDA PAI and general GMP inspection of two aseptic manufacturing plants and QC laboratory completed successfully03.06.17
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Industry News | Inspections
WuXi AppTec Bioanalytical Service Unit Passes FDA Inspection
Shanghai facility successfully completes audit and bioequivalence inspection03.01.17
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GMPs/GCPs | Inspections | QA/QC | Regulatory Affairs | Validation
Compliance Challenges
The importance of contract compliance during regulatory changeBill Adams, SC&H Group 01.26.17
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APIs | Cytotoxics and High Potency Manufacturing | Industry News | Inspections
Novasep Custom Mfg. Sites Complete FDA Inspections
Three sites in France and Germany pass U.S. FDA inspection12.20.16
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Industry News | Inspections
Akorn Completes FDA Re-inspection of Decatur Facility
Verifies the implementation and effectiveness of responses to previous observations12.12.16
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APIs | Inspections
Novasep
Novasep provides a full range of CMO and development services for the Life Science industries with a wide range of flexible assets on multiple sites. We are a world leader in HPAPIs (cytotoxics and ADC payloads), viral vectors for gene therapy &…Velvet Mitchem, Marketing Manager 12.06.16
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Breaking News | Facilities | Industry News | Inspections
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cGMP Manufacture | Industry News | Inspections
Evonik Birmingham Receives GMP Certification Renewal
Successfully completes inspection by the MHRA for the manufacture of sterile human medicinal products08.31.16
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Inspections
Pharma Life After Brexit
How will the pharma industry respond to the UK's exit from the EU?Ben Locwin, Healthcare Science Advisors 07.12.16
