Validation Times articles from November 2008

Validation Times archives from November 2008

Revised FDA guidance focuses on lifecycle approach to process validation.(Process Validation)
November 1, 2008... Following review by the Centers for Drugs, Biologics and Veterinary Medicine, FDA Nov. 17 issued a major revision to its 1987 landmark guidance, "Process Validation: General Principles and Practices," with a new draft guidance that stresses the...

FDA develops science- and risk-based QbR system to assess product quality.(CMC)
November 1, 2008... WASHINGTON -- The implementation of Question-based-Review (QbR) for ANDA evaluation is part of FDA's initiative to adopt a science-based approach to review. Integrating QbR for chemistry, manufacturing and controls (CMC) evaluation of new...

OGD promotes sterility DMFs to improve efficiency, maximize resources.(Sterilization)
November 1, 2008... WASHINGTON -- As acquisitions and mergers continue to push generic drug organizations global, FDA has equipped its offices with more staff and new processes to expedite and ensure thorough review of generic pharmaceuticals. While changes...

OGD takes initiative to ensure performance of generic drugs via drug quality initiative, QbR.(Generic Review)
November 1, 2008... WASHINGTON -- In 2009, the Office of Generic Drugs (OGD) will spread the word about generic medicines--safe, substitutable products that, in the midst of national economic struggle, are more in demand than ever before. "Being able to get...

Missing written procedures, process validation, and product specifications at Absolute Packaging.(Human Drugs)
November 1, 2008... FDA Investigator Kelly Anderson slapped Absolute Packaging with a 21-observation 483 following inspection of the company's Melbourne, FL, facility July 25-30, 2007. According to the 483, the firm had no written procedures for production and...

FDA cites Actavis Totowa for poor reporting, stability testing.(Human Drugs)
November 1, 2008... Following an inspection Sept. 5-28, 2007, FDA Investigator Kristy Zielny issued a three-item 483 to Actavis Totowa, a maker of generic drugs in Little Falls, NJ. In April 2008, the firm initiated a Class I nationwide recall of Digitek...

Lack of CAPA, control, and labeling procedures at EM Innovations.(Medical Devices)
November 1, 2008... EM Innovations, a specification developer of the Class II Stic Kit medical sharps container, received an eight-item 483 following an inspection at the Galloway, OH, facility Feb. 7-10, 2006, by the husband-and-wife team of investigators Jeffrey...

Repeat violations for defibrillator manufacturer.(Medical Devices)
November 1, 2008... FDA investigators Norman Wong and Nancy Saxerian-Emmons noted 32 separate instances of non-conformance to GNP/Quality System regulations in their inspection of Physio Control, Redmond, WA, Jan. 2-Feb. 6. Several instances of CAPA problems...

Merck's West Point facility receives 49 citations.(Blood & Biologics)
November 1, 2008... An FDA team conducted an inspection of Merck's vaccine facility in West Point, PA, over several weeks from November 2007 through January 2008, producing a 483 with 49 items citing multiple issues in the quality, production, laboratory,...

PrimaPharm violates GMPs.(Human Drugs)
November 1, 2008... GNP violations were found at PrimaPharm's drug manufacturing facility in San Diego, CA, during a May 1-14 inspection. In addition, the firm is manufacturing and/or marketing unapproved and misbranded drugs, FDA noted in the Oct. 31 warning...

Quality systems and procedures lacking at BioMedix.(Medical Devices)
November 1, 2008... A June 17-Aug. 6 inspection revealed that BioMedix was not in conformity with several GMP requirements. BioMedix manufactures the PADnet+, used in the diagnosis of damaged valves of the superficial venous system The St. Paul, MN, firm's...

FDA cites problems for manufacturer of diagnostic testing devices.(Medical Devices)
November 1, 2008... Health monitoring and testing product manufacturer Biosafe Laboratories was found in violation of GNP requirements following an inspection of its facilities May 15-June 2. The Chicago, IL, company produces an anemia meter and blood...

Devices not to spec at medical equipment firm.(Medical Devices)
November 1, 2008... An April 2-4 FDA inspection cited Magnificent Medical Equipment for its failure to maintain device history records (DHRs) to demonstrate that its devices were manufactured in accordance with the device master records (DMRs). In its Sept. 4...

Poor complaint handling at Power Medical Interventions.(Medical Devices)
November 1, 2008... Surgical cutting and stapling device manufacturer Power Medical Inventions was cited in an Oct. 21 warning letter for its SurgAssist System and Intelligent Surgical Instruments i60, i60S Linear and iDrive C, which violated GMP regulations. ...

Quality systems deficient at Swiss American Products.(Medical Devices)
November 1, 2008... Swiss American Products was in violation of GMPs, according to Aug. 12-15, Aug. 19 and 27 and Sept. 4 inspections of its Carrollton, TX, facility. The firm, which manufactures and distributes wound care products, was cited for procedural and...

Specimen testing and collection failures cited at fertility center.(Blood & Biologics)
November 1, 2008... FDA found significant deviations from the regulations for human cells, tissues and cellular and tissue-based products (HCT/Ps) during a June 17-24 inspection of the Center for Fertility and Gynecology in Tarzana, CA. Three semen donors...

Inadequate documentation and testing cited at fertility clinics.(Blood & Biologics)
November 1, 2008... Following a March 7-April 11 investigation of three human reproductive tissue establishments, agency officials noted deviations from the regulations for human cells, tissues and cellular and tissue-based products (HCT/Ps). Based in Carmel,...