Validation Times articles from March 2007

Validation Times archives from March 2007

FDA to get rid of regional offices, decrease district offices in downsizing under new ORA reorganization; lab inspections to be key focus in '07.(Compliance/enforcement)
March 1, 2007... ATHENS, GA -- Starting with the 2008 fiscal year (Oct. 1), FDA will get rid of its five regional offices, reduce the number of district offices from 20 to 16 and possibly decrease laboratories from 13 to six under a new reorganization of the...

Global GMP requirements pose difficulties for manufacturers.(International)
March 1, 2007... ATHENS, GA -- Global GMP regulations, guidelines and policy documents are increasing and advancing, but FDA regulators and its EU (European Union) counterparts are concerned that companies are not aware of the impact these proliferations will...

80% of Inspectorate audits focus on drug quality issues: Thorsky.(Inspections)
March 1, 2007... ATHENS, GA -- About 80% of audits conducted by FDA's five-year-old Pharmaceutical Inspectorate Program concern drug GMPs, the leader of FDA's Field Drug Committee told a University of Georgia conference here March 15. John Thorsky, who is...

Pfizer touts risk/science approaches to meeting 'Continuous Quality Verification'.(Verification/validation)
March 1, 2007... ATHENS, GA -- When making a decision regarding Continuous Quality Verification (CQV), industry should always use science and risk-based approaches to process validation, a Pfizer validation specialist said here March 14. Sabra M. Seyer,...

Hi-Tech written up for OOS and process validation in 10-item 483.(Human drugs)
March 1, 2007... Hi-Tech Pharmacal, Amityville, NY, received a 10-item 483 for several out-of-specification (OOS) results at the firm's contract laboratory, as well as for process validation flaws. FDA Investigator Robert Hora, Ph.D., conducted the...

Pre-approval audit nets 483 for aseptic filling room criteria.(Human drugs)
March 1, 2007... Hollister-Stier Laboratories, Spokane, WA, was slapped with a 10-item 483 in a GMP pre-approval inspection for not establishing criteria for investigating unexplained discrepancies in one of its aseptic filling rooms. Investigator Prabhu...

Cleaning validation, stability SOP trip up API manufacturer.(Human drugs)
March 1, 2007... Industriale Chimica, Sacronno, Italy, received a two-item 483 for incomplete cleaning validation in the manufacture of active pharmaceutical ingredients (APIs). The EIR stated that investigator Vlada Matusovsky from the Center for Drugs...

Validation process procedures nets 11-item 483 for Electrode Store.(Medical devices)
March 1, 2007... The Electrode Store, a medical device manufacturer in Buckley, WA, received an 11-item 483 because procedures were not implemented for monitoring and control of process parameters for validated processes, and also for two instances of flawed...

MicroSurgical Tech slapped with 483 for quality system, corrective/preventive actions.(Medical devices)
March 1, 2007... A six-item 483 went to MicroSurgical Technologies, Redmond, WA, because quality data was not appropriately analyzed, and CAPA procedures were not adequate. The audit was conducted from the Bothell, WA, District Office by investigator Deborah...

Actavis Totowa nets warning for QC, cleaning validation.(Human drugs)
March 1, 2007... A July 10-Aug. 10, 2006 inspection of Actavis Totowa, Little Falls, NJ, a prescription drug manufacturer, found significant deviations from GMP regulations which included the following: Significant deficiencies in the company's quality...

Niagara warned for potential eyewash contamination problems.(Human drugs)
March 1, 2007... Niagara Pharmaceuticals, Flamborough, Ontario, Canada, a manufacturer of an eyewash solution that contains purified water, was determined to have deviated from GMPs regarding the manufacture of sterile drug products. For example, the...

Edwards Life Sciences warned for quality data and CAPAs.(Medical devices)
March 1, 2007... An April 5-Aug. 10, 2006, inspection determined that Edwards Life Sciences, Irvine CA, was not in conformance with GMP/Quality Systems (QS) requirements for medical devices. Some of the deviations included the following: First was failure...

Fisher & Paykel written up for quality problems.(Medical devices)
March 1, 2007... An Oct. 25-Dec. 6, 2006 inspection found that Fisher & Paykel Healthcare, Irvine, CA, an assembler of radiant infant warmers and neo-natal accessory products, was not in conformance with current GMP requirements of the QS regulations for...

Failing to validate design nets warning for GE Healthcare.(Medical devices)
March 1, 2007... GE Healthcare Technologies, Waukesha, WI, was found to not be in full conformance with current GMP requirements of the Quality Systems regulation. The firm was cited in the Feb. 22 letter for failure to assure that only those devices that are...

Surgical drape maker cited for CAPAs validated process procedures.(Medical devices)
March 1, 2007... A manufacturer of surgical drapes--Medical Concepts Development, Woodbury, MN--was inspected Oct. 25-Nov. 8, and was determined to not be in line with current GMPs, FDA said in a warning letter. Deficiencies noted in the Feb. 2 warning...

Design and development plan flaws net warning for Newport Medical.(Medical devices)
March 1, 2007... Newport Medical Instruments, Costa Mesa, CA, a manufacturer of ventilators, was determined to be not in compliance with GMP/QS regulations. First, the Feb. 21 warning letter stated, the firm failed to establish and maintain plans that...

Rymed warned for lack of control of process parameters.(Medical devices)
March 1, 2007... An Oct. 18-Nov. 8 inspection of Rymed Technologies, Franklin, TN, the manufacturer and marketer of the Invision-Plus Neutral I.V. Connector Models and catheter extension sets, found the products were not in conformance with the Quality System...