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36 books found — Page 1 of 2
Medtronic Neurological draws 9-item 483 for design input, production process issues.(MEDICAL DEVICES): An article from: Inspection Monitor
Medtronic Neurological draws 9-item 483 for design input, p…
By: Unavailable
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OTC drug maker cited for failure to investigate deviations, provide GMP training.(Human Drugs): An article from: Validation Times
OTC drug maker cited for failure to investigate deviations,…
By: Unavailable
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USP workshop examines the role of bioassays in drug development.(Bioassays): An article from: Validation Times
USP workshop examines the role of bioassays in drug develop…
By: Carrie Nathans
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Wyeth vaccine facility faulted for quality, production and laboratory system controls.(BIOLOGICS): An article from: Inspection Monitor
Wyeth vaccine facility faulted for quality, production and …
By: Unavailable
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Contract Medical Manufacturing Oxford, CT, Nov. 20.(MEDICAL DEVICES): An article from: Warning Letter Bulletin
Contract Medical Manufacturing Oxford, CT, Nov. 20.(MEDICAL…
By: Unavailable
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DOE factors into bioassay development, says USP workshop.(Design of Experiments): An article from: Validation Times
DOE factors into bioassay development, says USP workshop.(D…
By: Carrie Nathans
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FDA questions process validity at Contract Medical Manufacturing.(Medical Devices): An article from: Validation Times
FDA questions process validity at Contract Medical Manufact…
By: Rebecca Mashaw
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Teva slammed with 16 GMP observations after audit of parenteral facility.(Human Drugs): An article from: Validation Times
Teva slammed with 16 GMP observations after audit of parent…
By: Rebecca Mashaw
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Wallach receives 10-item 483 for device design, process control issues.(MEDICAL DEVICES): An article from: Inspection Monitor
Wallach receives 10-item 483 for device design, process con…
By: Unavailable
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Medi-Stat cited for failure to conduct identity tests.(Human drugs): An article from: Validation Times
Medi-Stat cited for failure to conduct identity tests.(Huma…
By: Rebecca Mashaw
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Medical & Clinical Consortium slapped with 16-item 483.(Medical Devices): An article from: Validation Times
Medical & Clinical Consortium slapped with 16-item 483.…
By: Rebecca Mashaw
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Wyeth vaccine facility faulted for quality, production and laboratory system controls.(Biologics): An article from: Validation Times
Wyeth vaccine facility faulted for quality, production and …
By: Rebecca Mashaw
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CDER guidance for generics offers some help to OTC drug makers, but FDA may incorporate guidance in monographs.(Impurities): An article from: Validation Times
CDER guidance for generics offers some help to OTC drug mak…
By: Melissa Winn
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Pfizer given stern warning about PADE, PDMA compliance.(Human Drugs): An article from: Validation Times
Pfizer given stern warning about PADE, PDMA compliance.(Hum…
By: Unavailable
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Documentation failures at GE Healthcare IITS.(Medical Devices): An article from: Validation Times
Documentation failures at GE Healthcare IITS.(Medical Devic…
By: Rebecca Mashaw
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Inspectors focus on process design and implementation under ICH guidelines.: An article from: Inspection Monitor
Inspectors focus on process design and implementation under…
By: Melissa A. Winn
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FDA uses more than lab analysis of APIs to find fake drugs; excipient variation a major clue.(Counterfeiting): An article from: Validation Times
FDA uses more than lab analysis of APIs to find fake drugs;…
By: Tara Y. Coyt
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Organizations on both sides of the Atlantic address issues related to excipients.(Excipients): An article from: Validation Times
Organizations on both sides of the Atlantic address issues …
By: Liz Swain
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Cambrex warned about GMP violations at facility: Aug. 12-Milano, Italy.(Human Drugs): An article from: Validation Times
Cambrex warned about GMP violations at facility: Aug. 12-Mi…
By: Rebecca Mashaw
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Makers of non-actives to focus on quality systems, transparency and traceability.(Excipients): An article from: Validation Times
Makers of non-actives to focus on quality systems, transpar…
By: Carrie Nathans
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Validation, documentation problems found at Contract Medical Manufacturing.(Medical Devices): An article from: Validation Times
Validation, documentation problems found at Contract Medica…
By: Rebecca Mashaw
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Contract Pharmacal warned about manufacturing drugs without approved applications.(Human Drags): An article from: Validation Times
Contract Pharmacal warned about manufacturing drugs without…
By: Unavailable
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Teva slammed with 16 observations after audit of parenteral facility.(HUMAN DRUGS): An article from: Inspection Monitor
Teva slammed with 16 observations after audit of parenteral…
By: Unavailable
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PMT Corp. Chanhassen, MN, Dec. 3 Minneapolis District.(MEDICAL DEVICES): An article from: Warning Letter Bulletin
PMT Corp. Chanhassen, MN, Dec. 3 Minneapolis District.(MEDI…
By: Unavailable
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PMT failed to validate processes, FDA says in letter: Minneapolis District--Dec. 3.(Medical Devices): An article from: Validation Times
PMT failed to validate processes, FDA says in letter: Minne…
By: Rebecca Mashaw
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Inspection log.: An article from: Inspection Monitor
Inspection log.: An article from: Inspection Monitor
By: Unavailable
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Stericon Pharma warned about GMP significant violations of GMP regs.(Human Drugs): An article from: Validation Times
Stericon Pharma warned about GMP significant violations of …
By: Unavailable
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Amerifit Pharma slapped with 26-item 483 for failure to follow procedures.(HUMAN DRUGS): An article from: Inspection Monitor
Amerifit Pharma slapped with 26-item 483 for failure to fol…
By: Unavailable
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OTC drug maker cited for failure to investigate deviations, provide GMP training.(HUMAN DRUGS): An article from: Inspection Monitor
OTC drug maker cited for failure to investigate deviations,…
By: Unavailable
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FDA to start enforcing labeling requirements for OTC drug products Sept. 30.(Labeling): An article from: Validation Times
FDA to start enforcing labeling requirements for OTC drug p…
By: Melissa A. Winn
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McNeil plant that produced recalled children's OTC drugs cited for 20 observations in April inspection.(HUMAN DRUGS): An article from: Inspection Monitor
McNeil plant that produced recalled children's OTC dru…
By: Unavailable
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McNeil plant that produced recalled children's OTC drugs cited for 20 observations in April inspection.(Human Drugs): An article from: Validation Times
McNeil plant that produced recalled children's OTC dru…
By: Rebecca Marshaw
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