Bioresearch Monitoring Alert articles from March 2001

Bioresearch Monitoring Alert archives from March 2001

GLP computer system cited for `deviations'.(Lilly Research Laboratories)(Brief Article)
March 22, 2001... Lilly Research Laboratories, Greenfield, IN, Detroit District and CDER An FDA inspection team conducting a Good Laboratory Practices (GLP) data audit of Lilly Research Laboratories' toxicology facilities and automated operations found five...

Data falsity allegation only unearths some deficiencies.(MPI Research)(Brief Article)
March 22, 2001... MPI Research, Mattawan, MI, Detroit District Responding to a study that suggested a drug may cause cataracts, FDA conducted a GLP inspection of MPI Research, Mattawan, MI, to address alleged data falsification in a study, but found no...

Wyeth Research renovates, sails past multiple audits.(Brief Article)
March 22, 2001... Wyeth-Ayerst Research, Chazy, NY, New York District Wyeth-Ayerst Research, Chazy, NY, gave the New York district's Nancy Saxenian little to complain about during her GLP review of the non-clinical lab. Saxenian found no objectionable...

Problems found do not rise to FDA complaint.(WIL Research Labs)(Brief Article)
March 22, 2001... WIL Research Labs, Ashland, OH, Cincinnati District and CDRH A contract non-clinical laboratory in Indiana that had received an unrelated warning letter the previous year received a clean bill of health earlier this year when FDA inspectors...

GMP audit leads FDA to IOL firm's monitoring.(Medical Development Research)(Brief Article)
March 22, 2001... Medical Development Research, Clearwater, FL, Florida District FDA's inspection of Medical Development Research in Clearwater, FL, was apparently intended only as a GMP audit, but the intraocular lens maker's sponsor/monitor activities came...

Handling of study drug is focus of BiMo audit.(the clinical conduct of Dr. Mitchell Schiffman)(Brief Article)
March 22, 2001... Dr. Mitchell Shiffman, M.D., Richmond, VA, Baltimore District Investigator Candice Cortes of the Baltimore district spent five days reviewing the clinical conduct of Dr. Mitchell Schiffman, M.D. at the Medical College of Virginia in...

Personnel handwash protocols get clean audit.(Hill Top Research)(Brief Article)
March 22, 2001... Gayle Mulberry, Hill Top Research, Cincinnati, OH, Cincinnati District A pair of two-week studies to evaluate the antimicrobial effectiveness of an investigational "pre-surgical hand scrub handwash" passed an FDA inspection with flying...

After 3 audits, prestigious clinic fixes FDA problems.(Cleveland Clinic Foundation)(Brief Article)
March 22, 2001... Cleveland Clinic Foundation, Cleveland, OH, Cincinnati District An FDA examination of six studies being overseen by Cleveland Clinic Foundation's IRB led to a 483 citing the board's improper decision-making procedures, including votes cast...

Laid-back record-keeping fails So. Connecticut IRB.(Southern Connecticut State University,)(Brief Article)
March 22, 2001... Southern Connecticut State University, New Haven, CT, New England District The institutional review board of Southern Connecticut State University (SCSU) appeared a bit too laid back for an FDA inspector, who advised the board to begin...

BiMo Inspection Log.(Brief Article)
March 22, 2001... This is a list of requests for 483s and EIRs for inspections of CROs, testing labs, IRBs and clinical investigators, filed with FDA under the Freedom of Information Act (FOIA). These are only requests for document s. In most cases, these...

Warning and NIDPOE Letters.(Food and Drug Administration disciplinary actions)(Brief Article)
March 22, 2001... The following are recent FDA warning letters and Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) letters to clinical investigators. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE...

IRB Determination Letters.
March 22, 2001... The following are Compliance Determination Letters for IRBs issued in February and March by the National Institutes of Health Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to these...