Validation Times articles from May 2008

Validation Times archives from May 2008

Burden of proof of safety must fall on drug manufacturers: Woodcock.(Recalls/inspections)
May 1, 2008... Top FDA officials broke ranks with the Bush administration at a recent hearing of a House Energy and Commerce subcommittee, saying they would welcome Congress to grant it powers to order recalls of drug products, require foreign firms to...

Inspector finds Changzhou testing equipment 'unsuitable,' but MOU didn't help FDA get information.(Inspections/APIs)
May 1, 2008... An urgent February 2008 audit of the Changzhou SPL plant determined to be responsible for the contaminated heparin that reached 11 countries and killed at least 81 people in the U.S. found tanks used to process crude heparin that were scratched...

Dingell discussion draft requires inspection prior to importing any drug or device to U.S.; FDA disagrees.(Legislation)
May 1, 2008... The Food and Drug Administration Globalization Act of 2008, by House Energy and Commerce Committee Chairman John Dingell (D-MI), would require "an initial inspection before... any drug, active pharmaceutical ingredient, Class II or III device,...

FDA policy, IT limits failed in Baxter audit of Changzhou SPL.(Inspections/IT)
May 1, 2008... Baxter International did not send an inspector into the Changzhou SPL plant until February 2007, the inspection lasted only one day, and Baxter stated the plant was GMP compliant. FDA's February 2008 inspection--which ensued only after...

Berna Biotech cited for faulty media fill procedures.(Human drugs)
May 1, 2008... Berna Biotech, Berne, Switzerland, was hit with an 11-item 483 following a recent FDA inspection due to problems with its media fill procedures. Investigator Cynthia Jim from the Center for Drugs in Rockville, MD, conducted the audit. The...

Pulse Biomedical hit with 6-item 483 for design change flaws.(Medical devices)
May 1, 2008... Pulse Biomedical, Norristown, PA, received a six-item 483 because the firm failed to complete and follow procedures for the identification, validation or verification, review and approval of design changes. The investigation of the medical...

Quality SOPs trip up Sanofi Pasteur.(Biologics)
May 1, 2008... Sanofi Pasteur, Swiftwater, PA, was hit with a 12item 483 that outlined several SOP flaws in the company's quality system. The report was written by investigator Cynthia Jim of the Center for Drugs headquarters in Rockville, MD. "SOP...

Heparin manufacturer warned for failing to remove impurities.(Human drugs)
May 1, 2008... Changzhou SPL, Changzhou, China, which triggered a major international crisis regarding the safety of heparin and exposed FDA and drug manufacturers to heightened oversight from Congress, failed to adequately address issues cited in an agency...

Merck failed to investigate unexplained discrepancies.(Human drugs)
May 1, 2008... FDA investigators at Merck's West Point, PA, plant "documented significant deviations" from GMPs in the manufacture of several products at Merck's West Point, PA, facility, including Liquid PedvaxHIB, RECOMBIVAX HB, ProQuad, Gardasil, VAQTA...

Heartsine warned for failing to validate device design.(Medical devices)
May 1, 2008... Heartsine Technologies, Belfast, Ireland, the manufacturer of the Samaritan Automatic External Defibrillator (Samaritan AED) and the Samaritan Public Access Defibrillator (Samaritan PAD) devices, was determined to be in violation of GMPs...