Validation Times articles from April 2006

Validation Times archives from April 2006

FDA safety initiatives since '05 defended; Galson notes public, 'quantitation methods,' can influence risk/benefit ratio.(Drug safety)
April 1, 2006... WASHINGTON -- In his annual address to the nation's leading group of food and drug attorneys, Center for Drugs Director Steve Galson, M.D., vigorously defended FDA's oversight of drug safety, listing a series of initiatives in 2005 and also...

SOPs on production, process controls top 483 citations for drugs in '05.(GMPs/inspections)
April 1, 2006... ATHENS, GA -- "Written production and process control procedures not followed" was the No. 1 violation cited on 483s issued to drug manufacturers in fiscal 2005, followed by other SOP issues. This could be the first time in years that...

Effective quality system to ensure regulatory compliance essential in DOJ's eyes, says Hospira exec.(Quality systems)
April 1, 2006... WASHINGTON -- When designing a quality assurance system, keep in mind that if criminal charges are ever lodged against a firm, the U.S. Department of justice will take into consideration "the existence and adequacy of a corporation's compliance...

Total lack of validation is most-frequent finding, not 'inadequate' validation: FDAer.(Software validation)
April 1, 2006... WASHINGTON -- The most frequent problem at least in medical device inspections is not inadequate software validation testing, but a total lack of it, a Center for Devices official told the Food & Drug Law Institute annual conference here April...

2-item 483 to Central Admixture for faulty microbiological tests.(Human drugs)
April 1, 2006... An unannounced GMP inspection of Central Admixture Pharmacy Services, Santa Fe Springs, CA, uncovered the company's alleged failure to perform pyrogen testing on incoming stoppers, which are used in sterile talc. FDA stated this was...

Cima Labs receives 3-item 483 for control procedures, lab controls.(Human drugs)
April 1, 2006... An inspection of Cima Laboratories, Brooklyn Park, MN, resulted in the prescription and OTC drug manufacturer receiving a three-item 483 for faulty control procedures and a lack of written procedures for lab controls. However, in the follow-up...

Classic Cosmetics hit with 4-item 483 for lack of cleaning and process validation.(Human drugs)
April 1, 2006... Classic Cosmetics, Chatsworth, CA, a contract manufacturer of cosmetics and OTC drug products, was slapped with a four-item 483 for poor cleaning validation and a lack of process validation, as well as for inadequate equipment qualifications....

EEMSO cited numerous GMP record flaws in warning letter.(Medical devices)
April 1, 2006... On Jan. 24 and 31, and Feb. 1 and 16, FDA conducted an inspection of EEMSO in Dallas and determined the firm acts as a specification developer and an importer for the E Strip Disposable lontophoretic Treatment System and the High Voltage...

General Atomics slapped with letter for nonconformance procedures.(Medical devices)
April 1, 2006... An Oct. 31 to Nov. 9, 2005, investigation at General Atomics' Brea, CA, facility determined the manufacturer of in vitro diagnostic devices was not in conformance with the GMP requirements of the QS Regulation, as regarded the firm's methods...

Quality audit procedures come up short for In Vivo Metric Systems.(Medical devices)
April 1, 2006... A Sept. 13-30, 2005, FDA investigation of In Vivo Metric Systems, Hearldsburg, CA, a manufacturer of cutaneous electrodes, indicated the firm was not in conformance with the GMP requirements of the QS Regulations for medical devices. ...

MicroSurgical Technologies hit with letter for quality reports and records.(Medical devices)
April 1, 2006... A Nov. 8-10,14-16 and 21, 2005, FDA investigation conducted at MicroSurgical Technologies, Redmond, WA, a manufacturer of two ophthalmic surgical devices--Phaco Needles and Tips and the Oculo-Pressor--determined the firm was not in conformance...

Agile receives letter for quality issues related to software errors.(Radiologicals)
April 1, 2006... An FDA investigation of Agile Radiological Technologies, Cincinnati, OH, conducted between Jan. 17 and 27, revealed the manufacturer of the Radiation Analyzer (RAy) Film Dosimetry software product was not in conformance with the current GMP...