A newsletter for those involved in clinical trials. Published 20 times a year by Canary Ltd

FDA inspections

The following articles on this topic have been published in CRAdvisor (CRA) – the year, issue number and starting page number for each are listed below:

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2007  
CRA 2007; 186:2 FDA asks pharmaceutical companies to re-evaluate data generated by Canadian CRO.
CRA 2007; 187:6 CDER warning letters highlight investigator failings.
CRA 2007; 188:2 FDA inspection reveals falsified documents.
CRA 2007; 188:2 FDA inspection findings in Russia and Eastern Europe.
CRA 2007; 188:7 IRB fails to provide adequate subject protection.
CRA 2007: 190:2 US sponsor fails in trial conduct responsibilities.
CRA 2007; 190:5 Oklahoma IRB violates federal regulations.
CRA 2007; 191:6 FDA warning to IRB about working procedures.
CRA 2007; 192:7 CDER issues new warnings to investigators.
CRA 2007; 194:6 Protocol violation leads to FDA warning letters.
CRA 2007; 195:5 Florida-based sponsor violates device regulations.
   
2006  
CRA 2006; 166:5 Warning letters pick up more consent violations.
CRA 2006; 171:5 IRBs violate FDA regulations.
CRA 2006; 172:3 FDA uncovers violations of regulations: consent deficiencies predominate.
CRA 2006; 177:1 FDA warning letter highlights the need for careful subject recruitment and strict protocol compliance.
CRA 2006; 177:4 IRB breaches regulations on operation and responsibilities.
CRA 2006; 177:8 FDA orders company to cease manufacturing human cells and tissues.
CRA 2006; 178:1 Investigator jailed for 57 months.
CRA 2006; 178:6 Ineligible trial subject suffers gastric bleed.
CRA 2006; 180:4 CDRH inspections lead to new investigator warning letters.
CRA 2006; 181:5 FDA inspection of human pharmacology study reveals violations.
CRA 2006; 182:4 Conflicts of interest need evaluating for every trial.
CRA 2006; 182:5 FDA warns CRO over inspection findings in Canada.
CRA 2006; 182:8 Florida investigator fails to protect subject safety.
   
2005  
CRA 2005; 143:3 Principal investigator accountable for site deficiencies.
CRA 2005; 143:5 Recent FDA inspections lead to more investigators receiving warning letters.
CRA 2005; 143:7 OTC manufacturers more likely to be inspected by FDA.
CRA 2005; 144:3 Not just investigators! IRB receives FDA warning about its conduct.
CRA 2005; 147:3 Protocol violations ring alarm bells for FDA inspectors.
CRA 2005; 148:3 Violation of consent puts patients at risk.
CRA 2005; 148:8 FDA systems-based approach.
CRA 2005; 150:6 Investigator fails to impress inspectors.
CRA 2005; 151:1 FDA inspector unimpressed by explanation for serious trial violations.
CRA 2005; 151:3 How to respond to warning letters.
CRA 2005; 152:5 Warning letter criticises consent documents.
CRA 2005; 155:2 Inspection reveals trial commenced without IND.
CRA 2005; 157:2 FDA Centers issue 17 research-related warning letters in last 4 months.
CRA 2005; 158:3 Sponsors fail to meet regulatory obligations.
CRA 2005; 158:5 Alabama IRB continues to violate regulations.
CRA 2005; 160:4 Identifying the most frequent violations of FDA regulations.
CRA 2005; 161:6 CDRH issues more investigator warning letters.
   
2004  
CRA 2004; 123:3 Improving best practices: FDA warnings to sponsors reveal significant defects.
CRA 2004; 124:5 FDA warnings to manufacturers on PADE reports.
CRA 2004; 127:4 Warning letter for IRB that violates regulations.
CRA 2004; 133:3 Institutional review boards just do not learn - more inspection findings.
CRA 2004; 134:2 Drug manufacturer fails to report adverse drug experiences.
CRA 2004; 138:4 Busy summer for FDA inspectors: results of recent inspections.
CRA 2004; 139:1 FDA inspections reveal quality improvement in European trials.
CRA 2004; 142:5 ICH inspection procedures.
CRA 2004; 142:7 Serious violations in oncology study.
   
2003  
CRA 2003; 104:3 FDA disqualification, restrictions and debarrment of investigators.
CRA 2003: 105:2 FDA inspections: are you experienced?
CRA 2003; 110:3 FDA continues to punish IRBs that fail to comply with regulations.
CRA 2003; 112:1 FDA issues warning letter to volunteer death investigator.
CRA 2003; 112:2 Death of a volunteer - the background.
CRA 2003; 115:3 Learning points from FDA warning letters.
CRA 2003; 120:7 FDA inspection of 'incompetent' sponsor.
   
2002  
CRA 2002; 81:1 Training is key to Part 11 compliance.
CRA 2002; 82:4 Serious violations in sponsor-investigator study risked subject safety.
CRA 2002; 83:1 Surprise warning letter may be in store.
CRA 2002; 83:5 Deficient regulatory knowledge results in warning letter.
CRA 2002; 84:3 Investigators need close supervision to avoid inspection nightmares.
CRA 2002; 85:3 FDA orders investigator to receive training.
CRA 2002; 86:1 FDA requires speedier corrective actions.
CRA 2002; 87:4 Serious non-compliance leads to warning letters and law suits for cancer center.
CRA 2002; 88:1 Subjects enrolled prior to IND approval.
CRA 2002; 91:6 FDA inspections and guidance manuals.
CRA 2002; 95:3 FDA issues warning letter to Irvine IRB.
CRA 2002; 99:7 Paediatric protection under scrutiny.
   
2001  
CRA 2001; 62:6 FDA to disqualify IRBs.
CRA 2001; 63:3 FDA warning letter for gene therapy investigator.
CRA 2001; 67:2 FDA inspections down or compliance up?
CRA 2001; 67:5 Poor training of study site personnel results in FDA warning letter.
CRA 2001; 69:6 Higher budget set to increase number of FDA inspections.
CRA 2001; 70:1 'Hi-tech' FDA inspections.
CRA 2001; 70:2 Slow IRB response results in FDA warning letter.
CRA 2001; 70:3 Poor trial conduct results in warning letter.
CRA 2001; 72:1 Objectionable conditions found during FDA inspection.
CRA 2001; 74:1 Inspections MRA?
CRA 2001; 74:1 Violations may lead to FDA ban for investigator.
CRA 2001; 74:2 Sponsor cited for inappropriate device shipments.
CRA 2001; 74:5 Non-physician investigator upsets FDA.
CRA 2001; 75:1 Another IRB suspended by FDA.
CRA 2001; 75:6 MRA clarification.
CRA 2001; 76:1 FDA inspectors to issue 'recidicist letters'.
CRA 2001; 76:4 Patients waived rights to sue for trial violations.
CRA 2001; 79:6 False documentation leads to $33 million fine.
CRA 2001; 80:2 Use a 'control room' to avoid inspection irritations.
CRA 2001; 80:2 Deviations from Part 11 result in warning letter.
CRA 2001; 80:4 FDA oversight of foreign trials is criticised.
   
2000  
CRA 2000; 41:1 Trials in the USA?  Sponsors beware.
CRA 2000; 42:1 Investigator incurs wrath of FDA.
CRA 2000; 43:1 FDA set to increase number of sponsor inspections.
CRA 2000; 43:2 Record forms changes criticised in FDA warning letter.
CRA 2000; 49:1 Five FDA warning letters in two weeks.
CRA 2000; 49:1 Protocol violation leads to FDA action.
CRA 2000; 49:4 Form FDA 1572 in Europe.
CRA 2000; 49:4 Evidence of GCP training required by FDA.
CRA 2000; 50:1 Investigator used study drug when IND was on hold.
CRA 2000; 50:5 Complex protocol cause problems.
CRA 2000; 54:6 Investigators disqualified.
CRA 2000; 55:1 Breach of protocol led to serious adverse events.
CRA 2000; 56:3 Patients consented before IRB approval.
CRA 2000; 56:3 Sponsor must suspend study after FDA inspection.
CRA 2000; 59:3 Lack of safety reporting results in FDA warning letter.
CRA 2000; 59:5 Poor quality supervision leads to trial chaos.
   
1999  
CRA 1999; 22:1 Inadequate monitoring will precipitate warning letters! 
CRA 1999; 23:1 Clinical research manager goes to jail in USA! 
CRA 1999; 23:3 Concern raised about investigator understanding of responsibilities.
CRA 1999; 25:3 Usual problems still arise at inspections.
CRA 1999; 29:3 No IND approval for trials on unlicensed products.
CRA 1999; 32:1 FDA intolerant of poor monitoring.
CRA 1999; 33:1 FDA Form 1572 and trials in Europe.
CRA 1999; 35:6 FDA inspects University IRBs.
CRA 1999; 37:6 FDA denies targeting IRBs.
CRA 1999; 38:6 FDA shut down trials in Colorado.
   
1998  
CRA 1998; 3:1 Retrospective GCP compliance dangerous.
CRA 1998; 7:3 CRF changes need some explaining.
CRA 1998; 11:4 Device study violates FDA requirements.
CRA 1998; 14:4 FDA plans to inspect all players.
CRA 1998; 15:2 Concomitant medication and exclusion criteria.

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