Validation Times articles from April 2009

Validation Times archives from April 2009

QC unit failures, not following production procedures top human drug GMP 483 citations in FY '09.(Quality Control)
April 1, 2009... 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 controls--a persistent problem in inspections...

Corporate responsibility, transparency to guide CDER enforcement efforts, FDLI told.(Compliance/Enforcement)
April 1, 2009... 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 of 2009 will focus on unapproved drugs, supply...

FDA uses more than lab analysis of APIs to find fake drugs; excipient variation a major clue.(Counterfeiting)
April 1, 2009... 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 Manufacturing Practice conference here last month....

End of pilot program nears as FDA prepares to require electronic submissions only.(Electronic Submission)
April 1, 2009... 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 has been gearing up for the launch date since...

Acting Chief Scientist says agency needs to develop partnerships.(Science)
April 1, 2009... 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 partnerships may be the key to restoring...

Nephron follow-up inspection results in no warning.(Human Drugs)
April 1, 2009... 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 was required to comply with official actions...

Test methods and validation studies questioned at Pharmaceutics.(Human Drugs)
April 1, 2009... 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 of test methods had not been established, the...

Five-item 483 issued to Biolase.(Medical Devices)
April 1, 2009... 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 quality assurance at the company's Irvine, CA,...

Chattem fails to report label changes.(Medical Devices)
April 1, 2009... 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 removal injuries. This deviation from FDA's...

GMP violations still uncorrected at Edge Biologicals.(Medical Devices)
April 1, 2009... 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. Parker observed that the Memphis, TN, company,...

Lynn Medical Instrument Company cited for procedural failures.(Medical Devices)
April 1, 2009... 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 company's procedure for conducting quality audits...

Missing records at Donor Referral Services.(Blood & Biologics)
April 1, 2009... 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 2005. Agency officials Randy Clarida and Michelle...

Investigators slap MedImmune U.K. with 14-item 483.(Blood & Biologics)
April 1, 2009... 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 that MedImmune had not maintained appropriate...

Nine pharma companies warned for unapproved drug manufacture.(Human Drugs)
April 1, 2009... 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. All of the drugs listed are new drugs, FDA...

American Optisurgical strays from proper complaint handling procedure.(Medical Devices)
April 1, 2009... 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 the company, who manufactures and distributes...

FDA finds marketing of drug tests at Minnesota firm without premarket clearance.(Medical Devices)
April 1, 2009... 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. During the Oct. 28-29 audit, the firm...

PMA/IDE required for multiple IVD Research devices.(Medical Devices)
April 1, 2009... 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 Dengue IgG Microwell Serum ELISA, Dengue...

Validity assessment required at W.H.P.M., Inc.(Medical Devices)
April 1, 2009... 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 diagnostic (IVD) screening tests for drugs of...