Recently added articles from Inspection Monitor:
Biopharmaceutical firms push for harmonized audits to eliminate cost, duplication of effort.
Jun 01, 2009; Coyt, Tara Y. ... ATLANTA -- Biopharmaceutical manufacturers are eager for harmonized audits to avoid duplication of effort and save costs, which for some firms can be as high as $400,000 a day to achieve compliance in the U.S., EU and other nations with differing inspection approaches. ...
Hyaluron slapped with 14-item 483 for inadequate records, testing.(HUMAN DRUGS)
Jun 01, 2009 ... Hyaluron, Burlington, MA NE District FDA investigators Brenda King, Amber Wardwell and Anthony Warchut issued a 14-item 483 following their inspection of Hyaluron's drug manufacturing facility in Burlington, MA. Procedures to prevent microbiological contamination of ...
Procedural issues yield 3-item 483 for Millennium.(HUMAN DRUGS)
Jun 01, 2009 ... Millennium Pharmaceuticals, Cambridge, MA New England District Procedures covering handling of complaints and adverse events were deficient because they did not adequately detail the flow of information from Millennium Pharmaceutical's contract call center, FDA inspectors Brenda ...
SmithKline nets a single observation for improper testing of incoming shipments.(HUMAN DRUGS)
Jun 01, 2009 ... SmithKline Beecham, Bristol, TN Nashville District An inspection of SmithKline Beecham's Bristol, TN, site, dedicated to the manufacturing of non-sterile penicillin products for human and veterinary use, found just one deficiency, FDA investigator George Flynn noted on the 483 ...
API repackager gets slammed with 10-item 483 for quality system flaws.(HUMAN DRUGS)
Jun 01, 2009 ... Hawkins, Inc., Minneapolis, MN Minneapolis District FDA investigator Melissa Michurski observed multiple quality system failures in her inspection of API repackager Hawkins, Inc. Of 155 APIs repackaged by the company, the inspector observed that 123 lacked ...
FDA notes only two observations in 3M inspection.(HUMAN DRUGS)
Jun 01, 2009 ... 3M, Northridge, CA Los Angeles District An FDA inspection team issued a 483 with just two observations for 3M's facility for manufacture of prescription tablets, aerosols and transdermal patches. FDAers Uttaniti Limchumroon, Kelvin Sanders and Sarah Hassas cited the ...
Cardiac Science Corp. faulted for lapses in validation, CAPA, design history.(MEDICAL DEVICES)
Jun 01, 2009 ... Cardiac Science Corporation, Deerfield, WI Minneapolis District FDA investigators Joseph Edwin and Aaron Dunbar found that Cardiac Science Corporation had not validated and approved a process whose results could not be fully verified by inspection and test, they wrote on the ...
Inspection finds multiple quality system failures at Neurotone Systems.(MEDICAL DEVICES)
Jun 01, 2009 ... Neurotone Systems, Garland, TX Dallas District Neurotone Systems, a manufacturer of cranial electrotherapy stimulators, netted a 13-item FDA 483 from investigators Charles Brown and Rebecca O'Bryan, who found a widespread lack of controls, procedures and record-keeping. ...
Inspector cites Pharmaceutical Labs for laboratory control and quality system flaws.(CROs)
Jun 01, 2009 ... Pharmaceutical Laboratories and Consultants, Des Plaines, IL Chicago District Contract testing laboratory Pharmaceutical Laboratories and Consultants (PLC) received a 14-item 483 from FDA investigator Bruce McCullough for significant deviations from laboratory control and ...
Novartis nets 15-item 483 for problems at German vaccine facility.(BIOLOGICS)
Jun 01, 2009 ... Novartis Vaccines and Diagnostics, Marburg, Germany CBER The FDA inspection team of Omotunde Osunsanmi, Mihaly Ligmond and Robin Levis surveyed operations at Novartis Vaccines and Diagnostics in Marburg, Germany, Oct. 15-23, 2008, issuing a 15-item 483 at the close of inspection ...
Inspection log.
Jun 01, 2009 ... The following is a partial list of inspection documents that have been requested from FDA under the Freedom of Information Act (FOIA) by various parties, according to FDA's Freedom of Information Log. This is only a list of requested documents and in some cases, there may not be 483s or ...
