Validation Times articles from May 2005

Validation Times archives from May 2005

FDA issues warning on Able Labs' drugs after firm withdraws all from market for GMP reasons; CEO quits, stock price plunges $19/share in 1 week.(Compliance/enforcement)
May 1, 2005... FDA May 27 announced that patients taking drugs made by Able Laboratories, Cranbury, NJ--some of which were sold under the Breckeridge, Cypress, Hawthorn and Ivax label--should consider getting alternatives, just four days after the company...

PhRMA: RFID tags and paper pedigree requirement needed fast to stem counterfeit drugs.(Counterfeiting/RFID)
May 1, 2005... WASHINGTON -- With the flow of counterfeit drugs from Canada on the rise, serial identification on drug packaging--barcode or RFID [radio frequency identification] technology--needs to be implemented faster, and FDA should in the interim...

Cost-cutting industry 'SAFE' initiative enables secure electronic signatures.(Electronic records/signatures)
May 1, 2005... PHILADELPHIA -- The pharmaceutical industry's fragmented IT infrastructure--which relies on independent trust models and complicated processes for communication and cooperation between companies--may leave companies open to greater security...

PAT, data trending pose challenges to environmental monitoring.(Environmental monitoring)
May 1, 2005... PHILADELPHIA -- With FDA's increasing emphasis on process analytical technology (PAT), environmental monitoring methods and systems are evolving, but, according to Suggy Chrai, Ph.D., president and CEO of The Chrai Associates in Cranbury, NJ,...

Industry expert says calibration systems are too varied across companies despite GAMP.(Calibration/GAMP)
May 1, 2005... PHILADELPHIA -- The Good Automated Manufacturing Process (GAMP) Guide, released in 2003 by the International Society for Pharmaceutical and Medical Device Professionals (ISPE), addresses regulatory expectations for calibration systems and...

Fontarome Chemical receives clean report, but packing and cleaning validation errors noted.(Human drugs)
May 1, 2005... Despite not getting a 483 following a recent FDA audit, Fontarome Chemical, St. Francis, WI, did receive several comments from the agency about its packaging operations, cleaning validation and water system validation. Investigator Jeffery...

Firm hit with 483s for inadequate procedure for HPLC and water system problems.
May 1, 2005... Pharmaceutical Manufacturing Research Services, Horsham, PA, was hit with two consecutive 483s for a deficient procedure for calibrating its high-performance liquid chromatography (HPLC) system, and for not following SOPS for its water systems...

API manufacturer ducks 483, lack of process and cleaning validation cited.(Human drugs)
May 1, 2005... Westwood Chemical Corporation, Middletown, NY, a manufacturer of APIs, avoided a 483, but a lack of process and cleaning validation was noted in an inspection by Richard Glabach, an investigator from the Jamaica, NY, District Office. The...

Repacker/labeler nets 483 for MDR procedures, QA flaws, design controls.(Medical devices)
May 1, 2005... Tenacore Holdings, Santa Ana, CA, received a 10-item 483 for a lack of written MDR [Medical Device Record] procedures, an inadequate QA system and improper design controls. The firm also received a July 26, 2004, warning letter for the...

Baxter Healthcare fails to implement CAPAs at FL plant.(Medical devices)
May 1, 2005... An Oct. 12-22, 2004, inspection of Baxter's Largo, FL, manufacturing site determined the firm's hemodialysis devices did not conform to the GMP/Quality System (QS) regulations, according to a March 23 warning letter. Violations included...

No CAPAs and validation of test equipment for GE.
May 1, 2005... During a Nov. 15-Dec. 1, 2004, inspection of General Electric's Salt Lake City location, FDA determined the manufacturer of X-ray and fluoroscopic systems was not in conformance with the QS requirements. According to the March 31 warning...

Lack of validation and no documented design results for Inoveon.
May 1, 2005... An inspection from Dec. 7-21, 2004, determined that Inoveon, an Oklahoma City, OK, manufacturer of the Diabetic Retinopathy 3DT System, was not in conformance with QS rules, specifically, failure to establish and maintain procedures for...

St. Jude cited for lacking effective quality system, 'non-conforming results.(Medical devices)
May 1, 2005... St. Jude Medical's Caguas, PR, plant, did not have an adequate quality system, and FDA cited the firm for releasing batches of its Angio Seal Vascular Closure Devices despite "non conforming results," according to a March 17 warning letter. ...

Surgical Appliance Industries warned for not documenting calibration testing.(Medical devices)
May 1, 2005... An Oct. 4-6, 12 and 13, and Dec. 8, 2004, inspection of Surgical Appliance Industry, Cincinnati, OH, a manufacturer of medical support stockings, found the company did not establish procedures to comply with the QS regulations and current GMP...