Validation Times articles from September 2008

Validation Times archives from September 2008

Warning letters still down, with 32% citing validation; ORA reinventing itself.(Compliance/enforcement)
September 1, 2008... WASHINGTON -- FDA's fiscal year 2008 enforcement efforts so far have resulted in eight seizures, 373 warning letters and 2,804 recalled products--a slight decline in the number of products recalled and a slight increase in Class I recalls of...

FDA developing pilot on securing supply chain for APIs.(APIs)
September 1, 2008... WASHINGTON -- As the number of contaminated, mislabeled and insufficiently tested drug products continues to climb, FDA has realized major regulatory changes are in order. To better protect the welfare of consumers, the agency's efforts will...

CBER says it's more prepared than ever.(Biologics)
September 1, 2008... WASHINGTON -- The Center for Biologics (CBER) has been building quality systems for some time. "We're more prepared than we've ever been," said CBER's Director of the Office of Compliance and Biologics Quality Mary Anne Malarkey at the PDA/FDA...

Regulating drug products in global economy: FDA's perspective.(International)
September 1, 2008... WASHINGTON -- The global drug market is growing at record pace. Heparin was a wake-up call for FDA and pharmaceutical manufacturers, and now the agency must focus on prevention. But how can the contamination and compromised quality of drug...

China's path to product quality and safety.(International)
September 1, 2008... WASHINGTON -- China's rapidly growing pharmaceutical industry could mean a wealth of new and promising drugs, not only for Asian consumers, but for patients across the globe. Thriving production, however, means increased...

Good management: the key to culture change?(FDA management)
September 1, 2008... WASHINGTON -- Implementing change within a regulatory organization requires a collaborative effort. As far as policies, procedures and regulations are concerned, management may have the final say. But in many cases, it is the joint...

Documentation and testing procedures lacking at Hyaluron.(Human Drugs)
September 1, 2008... An FDA inspection of Hyaluron, a provider of aseptic services, revealed deviations from GMP regulations, specifically in production and control procedures, testing and sampling drug products and complaint handling and CAPA. Investigators...

Lilly cited for deficient corrective actions.(Human Drugs)
September 1, 2008... Despite FDA investigator Ernest Bizjak's 2006 findings of "no significant issues" upon a pre-approval inspection of Tippecanoe Laboratories, Eli Lilly's Lafayette API manufacturing facility, his 483 noted one item: a lack of corrective actions...

Phillips Plastics passes inspection.(Human Drugs)
September 1, 2008... A pre-approval inspection of Phillips Plastics conducted by Consumer Safety Officer Melissa Michurski resulted in no citations. Michurski completed the assessment for the manufacturing of sterile filled, small volume parenteral products....

Nine problems reported at Applied Water Engineering.(Medical Devices)
September 1, 2008... Investigator Ginger Sykes found lapses in management oversight, process and design controls, complaint handling and CAPA during an inspection of Applied Water Engineering July 7-11, 2006. The company manufactures reverse osmosis (RO) water...

Procedural lapses problematic for Quality Aspirators.(Medical Devices)
September 1, 2008... Following a March-April 2006 inspection, investigator Pauline Logan issued an 11-item 483 to Quality Aspirators, a manufacturer of surgical and dental devices. Logan cited Quality Aspirators with failure to evaluate or test software used...

Import Alert and warning letters issued for Ranbaxy Labs.(Human Drugs)
September 1, 2008... FDA halted importation of 30 generic drug products from Ranbaxy, India's biggest pharmaceutical company, and issued warning letters pertaining to GMP violations at two of its facilities in India. Under the Import Alert, officials may detain...

GMP violations cited at Cascadia.(Human Drugs)
September 1, 2008... FDA cited Cascadia for multiple GMP violations and for marketing products the agency classifies as new drugs without agency approval, following an inspection Jan. 31 and Feb. 1, 4, 11, 13 and 22. The FDA investigator found that appropriate...

Prismic Light markets unapproved drugs as dietary supplements.(Human Drugs)
September 1, 2008... After examining the company's product labeling and Web sites www.prismiclight.com and www.sandentco.com May 6-7, FDA concluded that its products are not dietary supplements, as claimed, but rather new drugs that FDA has not approved. The...

Manufacturing procedures questioned at Sandoz.(Human Drugs)
September 1, 2008... FDA emphasized concerns about problems in validation, testing and process control at the Sandoz manufacturing facility in Wilson, NC, following an inspection March 17-31. The company failed to establish and follow written procedures for...

DavisMade lacks design control procedures.(Medical Devices)
September 1, 2008... An inspection of DavisMade, which manufactures Standing Dani, Sprout and Kidster Dani wheelstand/wheelchairs, multi-positioning devices for physically handicapped children, found several violations of GMP regulations and that the company lacked...

Fall Prevention Technologies faulted for device design.(Medical Devices)
September 1, 2008... An inspection conducted May 5-21 revealed several violations of GMPs in the design and production of Fall Prevention Technologies' Balanceback iVNG--a device for recording, viewing and analyzing eye movements to help identify balance disorders...

Hair growth device marketed without FDA approval.(Medical Devices)
September 1, 2008... FDA notified Gaunitz Hair Sciences that it has been marketing the THL-1 Handheld Laser in the United States without marketing clearance or approval. CDRH reviewed the Web sites www.gaunitzlaser.com and www.hairgrowthcenters.com and found...

Documentation failures at GE Healthcare IITS.(Medical Devices)
September 1, 2008... An FDA inspection April 15-May 13 found several violations of GMP, including failure to properly document and report corrections and removals, in the company's processes for its Centricity Imaging and other Picture Archiving and Communication...

Adulterated devices found at O'Ryan Industries.(Medical Devices)
September 1, 2008... O'Ryan Industries, which manufactures the ENDO 150 endoscopic light source and imports the Omega ST Sterilizer (autoclave), had no PMA or IDE in effect for its devices, according to the FDA investigator who inspected the firm April 28-30 and...