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INSPECTION LOG.(Food and Drug Administration's Freedom of Information Log)(Brief Article)(Directory): An article from: Inspection Monitor
INSPECTION LOG.(Food and Drug Administration's Freedom…
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Failure to tell IRB of 4 deaths leads to 483s.(Institutional Review Board, Michael Jacoby, Mercy Ruan Neurology Clinic): An article from: Bioresearch Monitoring Alert
Failure to tell IRB of 4 deaths leads to 483s.(Institutiona…
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INSPECTION LOG.(inspection documents requested under Freedom of Information Act)(Brief Article): An article from: Inspection Monitor
INSPECTION LOG.(inspection documents requested under Freedo…
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Part 11 faults with lab equipment lift FDA concerns.(safety and security in pharmaceutical computer systems)(Brief Article): An article from: Validation Times
Part 11 faults with lab equipment lift FDA concerns.(safety…
By: Peter Dechnik
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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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Canada aims for 7-day approval for Phase I trials; rules redefine sponsors.(Canada): An article from: Bioresearch Monitoring Alert
Canada aims for 7-day approval for Phase I trials; rules re…
By: Tamra Sami
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BPD rule yields 35% jump in biologic adverse reports; labeling a leading cause.: An article from: Warning Letter Bulletin
BPD rule yields 35% jump in biologic adverse reports; label…
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Vaccine shortages abated, but FDA, CDC concerned about '01 outlook. (Food and Drug Administration, Centers for Disease Control and Prevention).(Brief Article): An article from: Validation Times
Vaccine shortages abated, but FDA, CDC concerned about …
By: Ken Reid
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AAI escapes 483 despite lack of validation data, testing deficiencies.(Human Drugs): An article from: Inspection Monitor
AAI escapes 483 despite lack of validation data, testing de…
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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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FDA, U.K.'s MCA can go own way on particle size, despite ISO guide.: An article from: Validation Times
FDA, U.K.'s MCA can go own way on particle size, despi…
By: Ken Reid
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HIPAA information security rules go live in 2005.(Health Insurance Portability and Accountability Act of 1996): An article from: Bioresearch Monitoring Alert
HIPAA information security rules go live in 2005.(Health In…
By: Gene Koprowski
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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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Abbott slapped with 483, warning letter for process control, software, cleaning and sanitation violations.(Human drugs): An article from: Validation Times
Abbott slapped with 483, warning letter for process control…
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'Loop calibration,' based on measures, saves BASF money.(Brief Article): An article from: Validation Times
'Loop calibration,' based on measures, saves BASF…
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IVD exporter caught with 'cat in the bag,' as FDA warns firm about rodent control, QS deficiencies.(Medical devices): An article from: Validation Times
IVD exporter caught with 'cat in the bag,' as FDA…
By: Tamra Sami
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NIST program gives six-step process for maintaining calibration services.(National Institute of Standards and Technology)(Brief Article): An article from: Validation Times
NIST program gives six-step process for maintaining calibra…
By: Mark Karbarz
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FDA letting industry determine how to roll out RFID; validation, CBE requirements noted.(Counterfeiting/packaging): An article from: Validation Times
FDA letting industry determine how to roll out RFID; valida…
By: Gail Dutton
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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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Analysis of 483s/EIRs for GMP validation issues.(Chemrich Holdings and Statson Pharmaceuticals environmental reports): An article from: Validation Times
Analysis of 483s/EIRs for GMP validation issues.(Chemrich H…
By: Mark McCarty
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CI fails to account for medical devices, maintain IRB approval.(Clinical investigators)(Orthopedic Specialties of Tampa Bay): An article from: Bioresearch Monitoring Alert
CI fails to account for medical devices, maintain IRB appro…
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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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INSPECTION LOG.(Brief Article): An article from: Inspection Monitor
INSPECTION LOG.(Brief Article): An article from: Inspection…
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INSPECTION LOG.: An article from: Inspection Monitor
INSPECTION LOG.: An article from: Inspection Monitor
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Revlon OTC drug process, computer, cleaning cited.: An article from: Validation Times
Revlon OTC drug process, computer, cleaning cited.: An arti…
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Nassmith's process validation, lab testing of OTC drugs cited.(over-the-counter)(Brief Article): An article from: Validation Times
Nassmith's process validation, lab testing of OTC drug…
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Nassmith exits OTC market after validation citations.(over the counter drugs)(Brief Article): An article from: Validation Times
Nassmith exits OTC market after validation citations.(over …
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2-2-0 updates FDA monthly on validation corrections.(Brief Article): An article from: Validation Times
2-2-0 updates FDA monthly on validation corrections.(Brief …
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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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Wyeth/Lederle audit led to $30 million consent decree.(Brief Article): An article from: Inspection Monitor
Wyeth/Lederle audit led to $30 million consent decree.(Brie…
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FDA not eyeing third party audits of raw materials; stressing C of As.(Excipients): An article from: Validation Times
FDA not eyeing third party audits of raw materials; stressi…
By: Tamra Sami
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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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