Inspections
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News | Inspections
Upperton Pharma’s Nottingham Site Passes MHRA Inspection
Gains licenses for manufacture, downstream processing into capsules and tablets, as well as spray dried formulations of biotherapeutics and small molecule APIs01.16.19
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Breaking News | Industry News | Inspections
Akorn Receives FDA Warning Letter
Akorn is working collaboratively with the FDA to resolve all issues related to an inspection of its Decatur, IL manufacturing facility01.09.19
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APIs | Breaking News | Facilities | Industry News | Inspections
CordenPharma Completes SafeBridge Recertification
Potent Compound Recertification Audit was conducted at Colorado site11.20.18
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Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
GRAM Completes Successful FDA Inspection
Following eight day inspection, GRAM was found to be in compliance with cGMP, with no Form 483 observations issued11.09.18
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Bio News | Industry News | Inspections
Avance Completes Successful FDA Inspection
Houston facility was successfully inspected by the U.S. FDA on October 1 through October 4, 2018.10.31.18
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Breaking News | Industry News | Inspections
Almac Completes HPRA Inspection at its European Campus
Can now support analysis of commercial drug product and provide flexible secondary labelling and packaging solutions10.26.18
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APIs | Breaking News | Cytotoxics and High Potency Manufacturing | Industry News | Inspections | QA/QC | Regulatory Affairs
Recipharm Audit Results in Licence Restriction
Five non-critical highly potent products from the Ashton-u-Lyne, UK site suspended due to potential cross contamination risk10.25.18
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Bio News | cGMP Manufacture | Industry News | Inspections | Scale-up/Technology Transfer
SEA Vision Launches HarleNir
Near Infrared Hyperspectral vision system can inspect an entire batch on the manufacturing line in a fully automated fashion10.22.18
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Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
Almac Completes Successful HSA Inspection
Underwent regulatory inspection by the Health Sciences Authority of its facility in Singapore10.22.18
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APIs | Breaking News | Facilities | Industry News | Inspections
Asymchem Passes FDA Inspection at API Mfg. Site
Reports successful FDA inspection of Tianjin 2 development and commercial manufacturing facility with no Form 483 issued09.14.18
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Bio News | Breaking News | Facilities | Industry News | Inspections
ADMA Biologics Reports Updated Compliance Status
FDA inspection database confirms VAI status of Boca Raton, FL facility09.05.18
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APIs | Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
Novasep Announces Successful FDA Inspection
At its API development and manufacturing site in Chasse-sur-Rhône, France08.27.18
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Facilities | Inspections | QA/QC | Regulatory Affairs
Are Indian Generic Firms Improving Compliance?
Indian firms take the generics battle to U.S. turf.Online Exclusives S. Harachand, Contributing Editor 08.09.18
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Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
Absorption Systems' ACF Bioservices Certified by MHRA
Certification warrants that facility is in compliance with the cGMP requirements after an April 2018 inspection by the MHRA08.07.18
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APIs | Bio News | Facilities | Industry News | Inspections
WuXi STA Site Passes Fourth Inspection
API manufacturing facility at Jinshan also passed FDA inspection in 2013, 2014 and 201607.26.18
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cGMP Manufacture | Facilities | Industry News | Inspections
Umicore API Facility Passes cGMP Audit
The plant manufactures four oncology APIs produced for global markets according to the latest international guideline06.20.18
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Inspections | Regulatory Affairs
PAI Readiness – A Journey, not an Event
A look at what you need to do to get ready for a pre-approval inspectionDr. Walter Matzmorr, Tunnell Consulting 06.12.18
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cGMP Manufacture | Industry News | Inspections
Pii Gets Positive Inspection News from FDA and MHRA
Previously restricted GMP Certificate withdrawn based on recent inspections by the FDA06.11.18
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cGMP Manufacture | Industry News | Inspections
Samsung BioLogics Receives Additional FDA Approval
Gains third approval for Plant 2 in 26 months05.24.18
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Bio News | Industry News | Inspections
Cytovance Biologics Completes FDA Inspection
The successful five-day process focused on quality systems, facilities, maintenance programs and manufacturing05.09.18
