Validation Times articles from December 2008

Validation Times archives from December 2008

FDA looks ahead to legislation to provide resources and authority to secure drug products.(Supply Chain Safety)
December 1, 2008... CORONADO, CA -- FDA is awaiting potential legislation that would give the federal agency more power, resources and tools to ensure a safe supply chain, administration representatives told members of the Parenteral Drug Assn. (PDA). FDA...

Organizations on both sides of the Atlantic address issues related to excipients.(Excipients)
December 1, 2008... CORONADO, CA -- In the aftermath of the deaths of 34 Nigerian children due to lethal ethylene glycol in teething powder, organizations on both sides of the Atlantic are working on plans to certify excipients. The role of third-party audits...

Combating counterfeit drugs is a global issue.(Counterfeiting)
December 1, 2008... CORONADO, CA -- Less than a week after PDA attendees heard about possible European Union legislation to combat drug counterfeiting, the European Commission (EC) proposed a requirement that pharmaceutical manufacturers audit companies that...

Industry reps make variety of suggestions for securing drug supply chain.(Supply Chain)
December 1, 2008... CORONADO, CA -- The assessment and management of risks helps ensure the integrity of the supply chain, industry and organization representatives told a PDA/FDA Pharmaceutical Ingredient Supply Chain Conference here Dec. 3-5. Mary Oates,...

Facility maintenance lacking at Accra Pac.(Human Drugs)
December 1, 2008... Following an inspection on June 12-21 and July 23, 2007, FDA Investigator William Nelson reported three cleaning-and maintenance-related problems at Accra Pac, a contract drug manufacturer. The company's facility in Elkhart, IN, was "not...

FDA investigator issues no warning, discusses concerns with management.(Human Drugs)
December 1, 2008... An investigation of Forest Pharmaceuticals, Cincinnati, OH, conducted Sept. 4-13, 2007, resulted in no 483, but some documentation citations on the EIR. FDA Investigator Mark Parmoni nspected the facility, which manufacturers solid, oral...

Unreported stability failures, SOP violations at Leiner Health Products.(Human Drugs)
December 1, 2008... FDA discovered multiple occasions where Leiner Health Products failed to properly conduct and follow up on stability tests for impurity, and neglected the investigation and documentation of out-of-specification results and discrepancies,...

Gebauer cited for inadequate procedures.(Medical Devices)
December 1, 2008... Vapocoolant manufacturer Gebauer was cited for procedures and complaint handling deficiencies, failure to investigate non-conforming products and other GMP violations in a report by FDA investigator Mishelle Harriger. The Cleveland, OH,...

Healthline fails to ensure quality systems.(Medical Devices)
December 1, 2008... Healthline Medical Products, which manufactures assist devices such as walkers and shower chairs, was cited by FDA investigator Richard Vogel for multiple violations of quality system regulations. Vogel inspected the company's Winter Garden,...

Lee Laboratories closes after FDA finds 21 GMP violations.(Medical Devices)
December 1, 2008... Lee Laboratories, a dental headgear manufacturer, shut down operations in March 2007 "rather than try to comply with all of the [FDA] required filings," according to records from an agency audit, which discovered 21 violations of GMP/Quality...

FDA notes inadequate staffing, poor quality control at NJ Blood Center.(Blood & Biologics)
December 1, 2008... FDA investigators Sarah Forney and Helen Ricalde issued a 483 following an Aug. 17-Dec. 27, 2007, inspection of the Blood Center of New Jersey (BCNJ). On three occasions, the company failed to have a qualified physician or trained person under...

Steven's Pharmacy cited for production volume.(Human Drugs)
December 1, 2008... Steven's Pharmacy, Costa Mesa, CA, was found by FDA in a Nov. 12 warning letter to be more than a compounding pharmacy. The agency wrote: "Our investigation found that your operation exceeds the practices associated with traditional...

Rx drugs mislabeled at Whitney Labs.(Human Drugs)
December 1, 2008... Citing GMP violations related to the repackaging and relabeling of prescription drug products, FDA inspectors reported serious deficiencies at Whitney Labs in Orlando, Fl, according to a Sept. 2 warning letter. The March 12-17 inspection...

Innovative Neurotronics fails to follow GMPs.(Medical Devices)
December 1, 2008... An inspection conducted in August and September revealed Innovative Neurotronics, Austin, TX, was in violation of several GMP requirements, FDA wrote in a Nov. 4 warning letter. The company is a specification developer and also manufactures...

Device manufacturer violates GMPs.(Medical Devices)
December 1, 2008... An Aug. 25-27 FDA inspection of PDS Manufacturing in Southlake, TX, found the company was not in compliance with GMP requirements. According to a Nov. 24 warning letter, PDS manufactures a cryosurgical system consisting of hand-held...