Validation Times articles from May 2009

Validation Times archives from May 2009

Biopharmaceutical firms push harmonized audits to eliminate cost, duplication.(Inspections)
May 1, 2009... 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...

Proposed FY 2010 budget targets medical product and food safety.(FDA)
May 1, 2009... FDA has requested a 19% budget increase for fiscal year 2010 (Oct. 1, 2009 through Sept. 30, 2010), which would yield a $3.2 billion budget aimed primarily at food safety, but also with millions for drug, device and biologic safety and GMP...

FDA says knowledge of overseas operations is vital to secure supply chain.(Import Safety)
May 1, 2009... WASHINGTON -- Ensuring a safe supply chain is a complex, ongoing process, and some at FDA feel they're working without a complete set of tools. "As the world has gotten bigger and complexity has increased, we don't have adequate information...

Cell source, reagents and validation key to FDA; Novocell, Lonza outline their methods.(Stem Cells)
May 1, 2009... ATLANTA -- Manufacturers seeking to market therapeutics from stem cells should focus their efforts on building quality into the product through the consistent control of cell source, reagents, facility, personnel and equipment, and the...

Genentech has 2 QbD proposals to CDER as EMEA seeks ways to ease difficulties for biotech drugs.(Quality by Design)
May 1, 2009... ATLANTA -- FDA has accepted two proposals from Genentech for a Center for Drugs pilot to make it easier for biotech products to use Quality by Design for review, and the agency, along with its European counterparts, is trying to ease the path....

Corrective actions lacking at First Priority.(Human Drugs)
May 1, 2009... During her Oct. 24-Nov. 9, 2006, inspection of veterinary drug manufacturer First Priority of Elgin, IL, Susan Bruederle found a number of violations, even after the firm had corrected deviations observed in its 2004 inspection. According to...

Iowa College of Pharmacy passes second inspection.(Human Drugs)
May 1, 2009... On Feb. 13, 2008, FDA Investigator Brent Hall conducted an inspection of the University of Iowa College of Pharmacy's Pharmaceutical Service Division (PSD), to verify corrective actions required following a previous inspection in 2007. ...

483 issued to Abbott Diagnostics.(Medical Devices)
May 1, 2009... Abbott Diagnostics International (ADI) did not fully comply with GMP regulations in its complaint handling and CAPA processes, according to an FDA-issued 483. Investigators Wanda Torres and Luis Carrion inspected the facility June 7-July 20,...

Insufficient procedures documented at TEFTEC.(Medical Devices)
May 1, 2009... The San Antonio, TX, manufacturer of OmegaTrac and BetaTrac powered wheelchairs, TEFTEC, did not comply with complaint handling, CAPA and design requirements, said FDA investigator Brenda Stewart-Munoz at the conclusion of her Feb. 6-March 10,...

CSL fails to take proper corrective actions.(Biologics)
May 1, 2009... A May 5-15, 2008, inspection revealed 14 violations at influenza vaccine manufacturer CSL Biotherapies. Investigators Omotunde Osunsanmi and Joan Adamo faulted the Victoria, Australia, facility for CAPA-related deficiencies. They noted...

GMP violations cited at Qingdao Jiulong Biopharmaceuticals.(Human Drugs)
May 1, 2009... April 14--CDER Appropriate systems and procedures were not in place at Qingdao Jiulong Biopharmaceuticals, according to FDA investigator Carl Lee and Compliance Officer Zi-Qiang Gu, Ph.D., who inspected the facility July 28-Aug. 1. ...

FDA cites heparin producer for outsourced manufacturing.(Human Drugs)
May 1, 2009... April 14--CDER An Aug. 4-7 inspection of Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd., which supplied some of the contaminated heparin involved in several injuries and deaths in the U.S. last year, revealed that the facility had...

Firm operated without approved applications.(Human Drugs)
May 1, 2009... April 10--New York District In addition to GMP violations, Time-Cap Laboratories manufactured a number of prescription drugs without approved applications, FDA inspectors found during a Oct. 28-Dec. 5 inspection. The Farmingdale, NY,...

Complaint handling procedures cited at Amrex Zetron.(Medical Devices)
May 1, 2009... April 14--Los Angeles District An Oct. 21-Nov. 3 inspection of Amrex Zetron, based in Carson, CA, revealed the company did not have a PMA or IDE for any of its neurological electrotherapy products. The company did not have adequate...

Validation procedures lacking at IDev Technologies.(Medical Devices)
May 1, 2009... April 9--CDER An inspection of IDev Technologies' corporate and production sites revealed GMP violations Dec. 9-Jan. 21. The company manufactures the SUPERA Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter. The...

St. Jude used unsupported processes in catheter manufacturing, FDA says.(Medical Devices)
May 1, 2009... April 17--Minneapolis District A Dec. 8-19 inspection of St. Jude Medical's Atrial Fibrillation Division in St. Paul, MN, found the ablation catheter manufacturer was not in conformity with GMPs. FDAers cited the company for failure to...