Validation Times articles from April 2008

Validation Times archives from April 2008

FDA needs $70 million more per year to inspect foreign drug plants: Commissioner von Eschenbach.(Inspections)
April 1, 2008... WASHINGTON -- FDA needs about $70 million more per year to overhaul the agency's overseas drug inspection structure so that the approximately 3,000 overseas drug facilities could be inspected every two years, Commissioner Andrew von Eschenbach,...

Legislation could be most significant change in drug law since 1962: CDER's Throckmorton.(FDAAA 2007)
April 1, 2008... WASHINGTON -- The Food and Drug Administration Amendments Act (FDAAA) 2007 is a "significant change in the regulatory paradigm," perhaps "the most significant change since 1962" when the Kefauver-Harris amendments to the Food, Drug and...

Hazard analysis simple, powerful method to identify risk, says Chatterjee.(Software validation)
April 1, 2008... One of the simplest yet powerful software validation tools is hazard analysis, which helps to semi-quantify and standardize the assessment you go through to identify risk. This allows companies to demonstrate where risks are early in the...

CBER in 2008 to focus on improving manufacturing and product quality, CBER director Goodman says.(Biologics)
April 1, 2008... WASHINGTON -- Top priorities for the Center for Biologics in 2008 include improving manufacturing and product quality by implementing risk-based and preventive compliance, product testing and development of standards, Center Director Jesse...

AvTech Laboratories receives clean audit.(CROs)
April 1, 2008... AvTech Laboratories, Portage, MI, a contract laboratory specializing in pharmaceutical products, bioanalytics, method development, and quantitative microbiology testing, received a clean inspection following a recent pre-approval GMP audit. ...

ArthoCare Corporation clears FDA audit.(Medical devices)
April 1, 2008... Despite being audited due to the receipt of a MedWatch report, ArthoCare Corporation, Sunnyvale, CA, got a clean bill of health from the GNP inspection, according to the FDA report prepared by investigator Iris Macinnes from the Irvine, CA,...

7-item 483 to device firm for acceptance /rejection of product.(Medical devices)
April 1, 2008... MCT Medical Products, San Antonio, TX, was slapped with a seven-item 483 because it did not document acceptance or rejection of incoming products. Dallas, TX, District Office investigator Brenda Steward-Munoz conducted the audit. The EIR...

Spinal USA hit with 14-item 483 for faulty design plan review.(Medical devices)
April 1, 2008... Spinal USA, Flowood, MS, was the recipient of a 14-item 483 because the device specification developer's design plans were not reviewed, updated and approved as needed. Inspectors Marvin Jones and Sidney Smith from the Nashville, TN,...

Sterilmed passes FDA inspection.(Medical devices)
April 1, 2008... Sterilmed, Maple Grove, MN, a reprocessor of medical devices, did not receive any citations in a recent inspection. Investigator Ralph Jemdal from the Minneapolis, MN, District Office conducted the audit. The EIR stated that the firm's...

Catalent Pharma cited for QC failures.(Human drugs)
April 1, 2008... During an inspection of Catalent Pharma Solutions, Raleigh, NC, between Nov. 6 and Nov. 15, FDA investigators documented a number of significant objectionable conditions relating to compliance with GMPs. According to the March 28 letter,...

GSK failed to report trial data, letter states.(Human drugs)
April 1, 2008... GlaxoSmithMine, Research Triangle Park, NC, failed to report data from clinical trials concerning adverse events related to the use of Avandia over several years, FDA concluded after an inspection of the firm's corporate headquarters Aug....

U.S. Apothecary Labs warned for test procedures.(Human drugs)
April 1, 2008... FDA deemed the drug product RadBlock adulterated as well as an unapproved new drug following a July 18-24 inspection that revealed significant deviations from GNP regulations at U.S. Apothecary Labs, Santa Fe Springs, CA. The agency found...

CAPA procedures trip up Philips Lifeline.(Medical devices)
April 1, 2008... In an audit of Philips Lifeline, Framingham, MA, FDA concluded that the 3000 and 6000 model Health Watch (HW) Personal Response System manufactured by the firm's subsidiary, Health Watch, in Boca Raton, FL, is adulterated because of violations...

Retro-Tech warned for QS, device design procedures.(Medical devices)
April 1, 2008... Retro-Tech, Dallas, TX, a specification developer and maker of the Retro-Tech RTD Bacteriostatic Wound Dressing, was found to be in violation with GNP requirements of the Quality System (QS) regulation following an FDA inspection conducted Jan....

Novartis Vaccines fails to assure sterility, letter states.(Biologicals)
April 1, 2008... FDA conducted an inspection of Novartis Vaccines and Diagnostics in Marburg, Germany, Sept. 2027. FDA investigators documented a number of significant deviations from GMP in the manufacture of the firm's Rabies Vaccine (RabAvert) and Diphtheria...