Validation Times

Browse past and current articles from this publication.

Biopharmaceutical firms push harmonized audits to eliminate cost, duplication.(Inspections)
ATLANTA -- Biopharmaceutical manufacturers are eager for harmonized audits to avoid duplication of effort and save costs, which for some firms can be as high as $400,000 a day to achieve compliance . . .

Proposed FY 2010 budget targets medical product and food safety.(FDA)
FDA has requested a 19% budget increase for fiscal year 2010 (Oct. 1, 2009 through Sept. 30, 2010), which would yield a $3.2 billion budget aimed primarily at food safety, but also with millions for . . .

FDA says knowledge of overseas operations is vital to secure supply chain.(Import Safety)
WASHINGTON -- Ensuring a safe supply chain is a complex, ongoing process, and some at FDA feel they're working without a complete set of tools. "As the world has gotten bigger and complexity has inc . . .

Cell source, reagents and validation key to FDA; Novocell, Lonza outline their methods.(Stem Cells)
ATLANTA -- Manufacturers seeking to market therapeutics from stem cells should focus their efforts on building quality into the product through the consistent control of cell source, reagents, facil . . .

Genentech has 2 QbD proposals to CDER as EMEA seeks ways to ease difficulties for biotech drugs.(Quality by Design)
ATLANTA -- FDA has accepted two proposals from Genentech for a Center for Drugs pilot to make it easier for biotech products to use Quality by Design for review, and the agency, along with its Europ . . .

Corrective actions lacking at First Priority.(Human Drugs)
During her Oct. 24-Nov. 9, 2006, inspection of veterinary drug manufacturer First Priority of Elgin, IL, Susan Bruederle found a number of violations, even after the firm had corrected deviations ob . . .

Iowa College of Pharmacy passes second inspection.(Human Drugs)
On Feb. 13, 2008, FDA Investigator Brent Hall conducted an inspection of the University of Iowa College of Pharmacy's Pharmaceutical Service Division (PSD), to verify corrective actions required fol . . .

483 issued to Abbott Diagnostics.(Medical Devices)
Abbott Diagnostics International (ADI) did not fully comply with GMP regulations in its complaint handling and CAPA processes, according to an FDA-issued 483. Investigators Wanda Torres and Luis Car . . .

Insufficient procedures documented at TEFTEC.(Medical Devices)
The San Antonio, TX, manufacturer of OmegaTrac and BetaTrac powered wheelchairs, TEFTEC, did not comply with complaint handling, CAPA and design requirements, said FDA investigator Brenda Stewart-Mu . . .

CSL fails to take proper corrective actions.(Biologics)
A May 5-15, 2008, inspection revealed 14 violations at influenza vaccine manufacturer CSL Biotherapies. Investigators Omotunde Osunsanmi and Joan Adamo faulted the Victoria, Australia, facility fo . . .

GMP violations cited at Qingdao Jiulong Biopharmaceuticals.(Human Drugs)
April 14--CDER Appropriate systems and procedures were not in place at Qingdao Jiulong Biopharmaceuticals, according to FDA investigator Carl Lee and Compliance Officer Zi-Qiang Gu, Ph.D., who ins . . .

FDA cites heparin producer for outsourced manufacturing.(Human Drugs)
April 14--CDER An Aug. 4-7 inspection of Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd., which supplied some of the contaminated heparin involved in several injuries and deaths in the U.S. l . . .

Firm operated without approved applications.(Human Drugs)
April 10--New York District In addition to GMP violations, Time-Cap Laboratories manufactured a number of prescription drugs without approved applications, FDA inspectors found during a Oct. 28-De . . .

Complaint handling procedures cited at Amrex Zetron.(Medical Devices)
April 14--Los Angeles District An Oct. 21-Nov. 3 inspection of Amrex Zetron, based in Carson, CA, revealed the company did not have a PMA or IDE for any of its neurological electrotherapy products . . .

Validation procedures lacking at IDev Technologies.(Medical Devices)
April 9--CDER An inspection of IDev Technologies' corporate and production sites revealed GMP violations Dec. 9-Jan. 21. The company manufactures the SUPERA Interwoven Self-Expanding Nitinol Bilia . . .

St. Jude used unsupported processes in catheter manufacturing, FDA says.(Medical Devices)
April 17--Minneapolis District A Dec. 8-19 inspection of St. Jude Medical's Atrial Fibrillation Division in St. Paul, MN, found the ablation catheter manufacturer was not in conformity with GMPs. . . .

QC unit failures, not following production procedures top human drug GMP 483 citations in FY '09.(Quality Control)
ATHENS, GA -- The top three drug GMP violations in fiscal 2009 involved failings in manufacturers' quality control units, failure to adhere to production procedures and validation, but laboratory co . . .

Corporate responsibility, transparency to guide CDER enforcement efforts, FDLI told.(Compliance/Enforcement)
WASHINGTON, DC -- Improving corporate responsibility, not just boosting its overseas inspections presence, will be a key ingredient to Center for Drugs enforcement efforts, which for the remainder o . . .

FDA uses more than lab analysis of APIs to find fake drugs; excipient variation a major clue.(Counterfeiting)
ATHENS, GA -- Laboratory analysis is only one tool in FDA's armamentarium of weapons to combat counterfeiting, including excipient source and grade, an FDA chemist told the International Good Manufa . . .

End of pilot program nears as FDA prepares to require electronic submissions only.(Electronic Submission)
BALTIMORE, MD -- FDA is gearing up for going live with its requirements for electronic submission of drug establishment and listing information, still slated to go into effect June 1. The agency h . . .

Acting Chief Scientist says agency needs to develop partnerships.(Science)
WASHINGTON, DC -- In very frank commentary on the state of FDA's reputation among American consumers, Acting Chief Scientist Jesse Goodman, M.D., told the FDLI annual meeting in Washington that part . . .

Nephron follow-up inspection results in no warning.(Human Drugs)
Nephron Pharmaceuticals received a clean bill of health following a Feb. 7-11, 2008, inspection. The assessment was a follow-up to a 2007 investigation, which resulted in a 483. At the time, Nephron . . .

Test methods and validation studies questioned at Pharmaceutics.(Human Drugs)
During a June 4-26, 2007, inspection of contract drug manufacturer Pharmaceutics International, agency officials Kenneth Nieves and Tara Gooen found several lapses in lab procedures. Specificity o . . .

Five-item 483 issued to Biolase.(Medical Devices)
Several deficiencies were found during an Aug. 8-17, 2006, inspection of dental laser manufacturer Biolase. FDA investigator James Fleckenstein recorded complaint handling procedures and a lack of q . . .

Chattem fails to report label changes.(Medical Devices)
Chattanooga, TN, company Chattem failed to report labeling changes made to its Icy Hot Heat Therapy patches after receiving at least 168 customer complaints of burns, skin irritation and skin remova . . .

GMP violations still uncorrected at Edge Biologicals.(Medical Devices)
Edge Biologicals failed to correct deficiencies identified in previous inspections to better conform with GMPs, noted FDA inspector Cherie Parker, during a Jan. 29-Feb. 2, 2007, investigation. Par . . .

Lynn Medical Instrument Company cited for procedural failures.(Medical Devices)
Due to its failure to establish a variety of quality procedures, Lynn Medical Instrument Co. received a nine-item 483 following an inspection of its Wixom, MI, facility Feb. 6-21, 2008. The compan . . .

Missing records at Donor Referral Services.(Blood & Biologics)
Donor Referral Services, a human tissue recovery firm based in Raleigh, NC, was unable to supply FDA investigators eligibility records for individuals who donated tissue between May and December 200 . . .

Investigators slap MedImmune U.K. with 14-item 483.(Blood & Biologics)
MedImmune U.K. received a 14-item 483 following an inspection of its Liverpool facility March 21-23 and 26-29, 2007. FDA investigators Mihaly Ligmond, Omotunde Osunsanmi and Steven Rubin found tha . . .

Nine pharma companies warned for unapproved drug manufacture.(Human Drugs)
March 30--CDER (see table next page) CDER sent warning letters to nine pharmaceutical companies and distributors (listed below) concerning the manufacture and/or marketing of unapproved drugs. A . . .

American Optisurgical strays from proper complaint handling procedure.(Medical Devices)
March 16--Los Angeles GMP violations were noted during an Oct. 21- Nov. 5 of American Optisurgical's Irvine, CA, facility. Agency officials documented the deviations in a warning letter sent to th . . .

FDA finds marketing of drug tests at Minnesota firm without premarket clearance.(Medical Devices)
March 12--Minneapolis At an inspection of Express Diagnostics International in Blue Earth, MN, FDA investigators concluded the firm is marketing drug of abuse tests without an approved PMA or IDE. . . .

PMA/IDE required for multiple IVD Research devices.(Medical Devices)
Feb. 26--Los Angeles An FDA inspection conducted Sept. 9-Oct. 9 determined that IVD Research did not have approved applications for several of its devices. The firm lacked FDA approvals for its . . .

Validity assessment required at W.H.P.M., Inc.(Medical Devices)
March 19--Los Angeles District During its Dec. 1-19 inspection of W.H.P.M., Inc., FDA found the company "lacked any reliable source documentation. for the cleared 510(k)s for its in vitro diagnost . . .

FDA pilot, new overseas office, ICH approach seen helping with security, but China overwhelmed.(Supply Chain Integrity)
ATHENS, GA -- FDA, acknowledging the increasing complexity of supply chains and that capacity will not allow for robust inspections of all ingredients, is placing greater emphasis on US manufacturer . . .

Continued verification of processes warrants trending, assessing data: Famulare.(Process Validation)
ATHENS, GA -- For continued process verification, manufacturers should trend/assess data and monitor and reference current GMPS--21 CFR 211.180-(e)--which states that data should be evaluated at lea . . .

Supply chain 'insufficient' with foreign goods, CDER compliance chief says; counterfeiting growing in Canada.(Imports/Supply Cha
ATHENS, GA -- The United States must proactively address the challenges globalization has presented on imported drug products, according to speakers at the University of Georgia's 34th Annual Intern . . .

China's FDA still overwhelmed by applications and plants to cover.(APIs)
ATHENS, GA -- In China, new government intervention and regulations have improved the manufacturing of ingredients and drug products over the past few years, said Weiping Li, head of regulatory affa . . .

Software led 483 validation citations in '08.(Software Validation)
ATHENS, GA -- Process validation and, in particular, software validation, "continued to be among the more common 483 observations," Ronald F. Tetzlaff, Ph.D., corporate vice president of Parexel Con . . .

ICH Q10 implementation, incorporation into EU GMP Guide seen by summer 2010.(Inspections)
ATHENS, GA -- A working group of the International Conference on Harmonization (ICH) has composed a concept paper on the implementation of ICH Q10 and a proposal to incorporate Q10 as a new annex to . . .

Pascal cited for sterility, cleanliness and testing deficiencies.(Human Drugs)
Seventeen violations were recorded during a March 28-April 18, 2006, inspection of Bellevue, WA, drug manufacturing facility Pascal. FDA investigators Brenda Rohring and Terri Dodds, working with . . .

Unigen warned for testing and record-keeping failures.(Human Drugs)
FDA investigator Brooke Seeman inspected Unigen Pharmaceuticals March 5-22, 2007, citing the company for 18 process deviations. The investigator found that the Westminster, MD, company had no meth . . .

GMP violations at Wallach.(Medical Devices)
FDA investigators Elizabeth Griffin and Anthony Onianawa issued a 10-item 483 following an inspection of Wallach Surgical Devices' Orange, CT, facility June 6-9, 2006. The FDAers faulted Wallach f . . .

Process failures cited at Medtronic Neurological.(Medical Devices)
During a May and June 2006 inspection of Minneapolis, MN, Medtronic Neurological, FDA investigator Kellie Westerbuhr and Compliance Officer Timothy Phillips found that the company's design input wor . . .

Quality control lacking at Cyclotron Center of NE Florida.(Human Drugs)
Jan. 29--Florida District A July 31-Aug. 7 inspection of Cyclotron Center of NE Florida revealed substantial deviations from the United States Pharmacopoeia (USP) compounding standards and officia . . .

Non-compliant manufacturing processes at Genzyme Corporation.(Human Drugs)
Feb. 27--New England District FDA investigators noted GMP violations in the production of licensed therapeutic drugs, bulk drug substances and drug components during an inspection of Cambridge, MA . . .

FDA inspection discovers unapproved drugs at Prime Enterprises.(Human Drugs)
Jan. 29--Florida District Human and veterinary drug products and cosmetics manufacturer Prime Enterprises was found in violation of GMPs following a July 28-Aug. 1 inspection. FDAers documented re . . .

Stability failures noted at Taro Pharmaceuticals U.S.A.(Human Drugs)
Feb. 5--CDER A July 28-31 inspection of Taro Pharmaceuticals, which manufactures non-sterile cream and ointment finished drug products, resulted in a warning letter to the Canadian firm, citing "m . . .

CAPA procedures and GMP compliance cited at Alba Bioscience Limited.(Medical Devices)
Feb. 3--CBER During an Oct. 6-13 inspection, Alba Biosciences, which manufactures blood grouping reagents (BGR) that are classified as medical devices, FDA officials observed "a number of signific . . .

Documentation lacking at Medical & Clinical Consortium.(Medical Devices)
Feb. 2--Los Angeles District Drug and abuse test kit manufacturer Medical & Clinical Consortium was warned for its lack of conformity with GMPs following an inspection March 18-20, 25 and 31, 2008 . . .