Validation Times articles from October 2008

Validation Times archives from October 2008

Country of origin labeling for human drugs looms; China on FDA radar screen.(Counterfeiting/Imports)
October 1, 2008... WASHINGTON -- Country of Origin Labeling (COOL) legislation for food items became effective in September, requiring retail grocery stores to list products' country of manufacture. Similar regulations could one day apply to pharmaceutical...

Volume and consumer demand challenge import process.(Imports)
October 1, 2008... WASHINGTON -- The volume of products imported to the U.S. remains the biggest challenge to regulators, an FDA import operations official told the FDLI conference Oct. 24. John E. Verbeten, director of the ORA's division of import...

EMEA to roll out 'EudraGMP' to track inspections, seeks global harmonization.(International)
October 1, 2008... WASHINGTON -- Although European manufacturing sites are inspected every two to three years, the EMEA still faces challenges that stem from a rapidly expanding global market. Insufficient resources, increasing regulatory requirements and a surge...

Makers of non-actives to focus on quality systems, transparency and traceability.(Excipients)
October 1, 2008... WASHINGTON -- Excipients comprise a broad group of substances that range from food ingredients to specialist chemicals. Because these materials are so diverse, traceability and security of excipients are as crucial to drug safety as any part of...

Ruger cited for tracking and training flaws.(Human Drugs)
October 1, 2008... The initial inspection of Ruger's new facility in Linden, NJ, April 3-7, 2006, netted an eight-item 483 for failures in controls, training, record-keeping and complaint handling by the API manufacturer, repackager and relabeler. ...

Abraxis labeling and aseptic procedures not to spec.(Human Drugs)
October 1, 2008... Investigators Carrie Ann Plucinski and Russell Riley gave Abraxis a three-item 483 after an inspection of the drug manufacturer Aug. 23-Sept. 28, 2007. The inspectors found that Abraxis approved and released for use labeling and packaging...

Validation methods and documentation lacking at Ben Venue.(Human Drugs)
October 1, 2008... Drug manufacturer Ben Venue Laboratories did not adequately establish or validate testing methods and the company lacked appropriate written procedures in certain aspects of its operations, investigators Mark Parmon and Stephen Kilker found...

Investigators find reporting, audit failures at American Orthodontics.(Medical Devices)
October 1, 2008... American Orthodontics, a manufacturer of Class I and II orthodontic devices, was cited for failures in documenting CAPA and maintenance, conducting quality audits and appropriately reporting MDRs to FDA. Investigator Kimberly...

DHRs missing at Davol.(Medical Devices)
October 1, 2008... When FDA investigators Elizabeth Griffin and Courtney Long inspected Davol, which manufactures hernia patches, Jan. 25-Feb. 7, 2006, they found that no device history records could be located for two finished product lots that were distributed....

Mays and Associates cautioned for insufficient procedures.(Medical Devices)
October 1, 2008... The inspection of Burke L. Mays, specification developer for electroencephalography and polysomnography systems, conducted Oct. 23-24, 2006, by investigator Cheryl Scott, revealed a lack of adequate procedures, resulting in a three-item 483....

Concept Laboratories cited for stability issues.(Human Drugs)
October 1, 2008... Concept Laboratories was cited for making unapproved and misbranded new drugs, plus a variety of GNP violations, following an inspection conducted Dec. 12, 2007 Jan. 18. The company's Drug Stability Long-Term Report for the Skin Lightening...

Pharmalucence deviates from GMP regulations.(Human Drugs)
October 1, 2008... An FDA inspection of Pharmalucence April 7-30 documented significant deviations from GNP regulations for finished pharmaceuticals, FDA stated in a warning letter to the firm. The company failed to establish and follow written procedures...

Documentation and complaint handling noted at Alpine Oral Care.(Medical Devices)
October 1, 2008... An FDA investigator found that Alpine Oral Care, which manufactures and distributes dental flossers and mouth guards intended for protection against bruxism and nighttime teeth grinding, was not in compliance with GNP regulations after an...

The Lifestyle GP cited for outdated and unenforced procedures.(Medical Devices)
October 1, 2008... The Lifestyle GP Company, a manufacturer of daily wear contact lenses, was found in violation of GMP requirements following an inspection Jan. 29-Feb. 1. The Lifestyle GP Company procedures acquired in the original sale in 2002 were never...

Inspection reveals poor equipment checks, corrective actions at Technomed Europe.(Medical Devices)
October 1, 2008... An inspection of Technomed Europe June 9 June 12 found a number of violations of GMPs at the facility, which manufactures Diagnostic Electromyograph Needles, Radiofrequency Lesion Probes, Needle Electrodes, Cutaneous Electrodes and...