Vol. 2, No. 34
| Friday, Aug. 22, 2008 | FDA Orders Seizure After Firm Refuses to Recall Supplements
U.S. marshals acting for the FDA seized two lots of Miami-based SEI Pharmaceuticals’ Xiadafil VIP tablets that the company refused to recall at the request of the agency. An FDA chemical analysis of Xiadafil VIP tablet lots 6K029 and 6K029-SEI found that the product contained an undeclared ingredient, hydroxyhomosildenafil, the agency said. The chemical is similar to sildenafil, the active ingredient in Viagra (sildenafil citrate), which is approved to treat erectile dysfunction (ED). The agency says it has not approved Xiadafil VIP for ED or any other drug use and the product’s safety and effectiveness are unknown. Mark Hirsch, a medical team leader in Center for Drug Evaluation and Research’s Division of Reproductive and Urologic Products, said that “taking sildenafil in addition to certain prescription drugs containing nitrates may lower blood pressure to an unsafe level.” Following its analysis of the tablets, the FDA initiated an inspection April 22 at SEI and informed the company of the product’s potential adverse health risks. Florida state officials then issued a “stop sale” action May 13 at SEI’s distribution facility to keep the illegal product out of the marketplace, according to the FDA. The agency says it asked the company to recall the tablets May 27. Although SEI committed to halting distribution, it refused to recall the product already on the market, the agency says. Having warned the company of possible legal actions, the FDA asked the U.S. marshals to seize the product to keep it from being sold or distributed at trade shows, the agency says. The company declined to comment. IOPI Northwest Gets Warning Letter for Lack of Quality Audit
IOPI Northwest allegedly failed to conduct a quality audit for a device to diagnose speech and swallowing disorders, earning it a warning letter. An inspection of the company’s manufacturing facility in Carnation, Wash., revealed several GMP violations with its Iowa Oral Performance Instrument, including failure to establish auditing procedures, the letter says. The June 25 letter, posted recently to the FDA website, claims the company also did not establish procedures for corrective and preventive actions and complaint handling. Other violations noted include incomplete device history records, poor maintenance of acceptance activities and improper records showing testing, reviews or approvals of finished devices. The letter cites a statement that was on the company’s website: “The IOPI is registered with the FDA, but it is not ‘approved’ because the FDA does not approve medical devices.” The letter informs the company, “Establishments, not devices, are registered with FDA” and adds that the agency does approve certain Class III devices. It told the company to correct such misstatements. The letter is available at www.fda.gov/foi/warning_letters/s6855c.pdf. Vaccine Production Issues for Merck Are Subsiding
Merck has resolved a warning letter citing GMP violations at its vaccine operations in West Point, Pa., as well as supply constraints for bulk varicella, which had affected sales of certain vaccines. During its second-quarter earnings call last month, the company said the FDA closed out a warning letter that claimed bulk drug substances for many of Merck’s vaccines were adulterated. The letter resulted from an inspection that cited 49 Form 483 observations, all but 12 of which were resolved before the letter was issued, the company said. “On July 10, Merck received a letter from the FDA closing out its recent inspection at the West Point manufacturing facility. As a result, any filed sBLAs which were held up due to the inspection can now move through the agency’s normal review and approval process,” Merck CEO Dick Clark said during the firm’s second-quarter earnings call. “Concerning supplements, we have at least two supplements with the FDA concerning Gardasil [human papillomavirus quadrivalent (Types 6, 11, 16, and 18) vaccine, recombinant] and they will move through the [review] process,” he said. Merck said the supplements are for expanded labeling for Gardasil. The company planned to respond in July to an FDA complete response letter for the use of the vaccine in women 27–45 years of age. | Medical Device Supplier Audit
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St. Jude Reveals FDA Approval of Puerto Rico Plant
St. Jude Medical, Inc. announced U.S. Food and Drug Administration approval of its new facility in Arecibo, Puerto Rico, for the manufacturing of pacemakers and cardiac leads.
RTTNews Medical Devicemaker to Expand, Gets State Tax Credit
Terumo Cardiovascular Systems plans a $3.57 million expansion of its Ann Arbor facility and will relocate R&D and manufacturing from California, creating 65 jobs [in Michigan].
mlive.com APP Receives Manufacturing Approval for Three Product Codes of Heparin
APP Pharmaceuticals … said that the U.S Food and Drug Administration has approved APP's manufacturing facility in Barceloneta, Puerto Rico for the manufacture of three product codes of Heparin Sodium Injection, USP.
Fox Business Hindustan Latex to Manufacture Medical Devices
Condom major Hindustan Latex Limited announced it will set up a MediPark near Chennai to manufacture diagnostic devices to boost the Rs.25 billion medical devices market.
The Economic Times Shire, Momentive Projects Got Away From N.C., Local Recruiters
A major pharmaceutical company and a silicone products manufacturer that had considered locating separate multimillion-dollar projects in the Triangle region have instead chosen sites in competing states.
Triangle Business Journal Tri-Star Signs Agreement for ERHU Manufacturing Facility
Tri-Star Holdings, Inc., formerly Rapid Fitness, Inc., a publicly traded company currently on the Over the Counter, announced the company has signed a purchase agreement for a new 4000 ft. warehouse facility for the manufacturing of ERHU, Inc.
Yahoo! Finance | Third-Party Inspections:
Saving Devicemakers Time and Money
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Tuesday, Sept. 9, 2008 • 1:30 p.m. – 3:00 p.m. EDT
Hear about how medical device firms have benefited from third-party inspections in this 90-minute audioconference. FDA third-party audit program manager Gregor Dzialas will explain why third-party inspections are a better option and what you can learn from firms who have already engaged in them.
Register online or call toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600. |
| Third Annual FDA Inspections Summit
Wednesday, Oct. 15–17, 2008 • Bethesda, MD (Washington, DC)
Join us for a rare opportunity to interact with top officials — including five from the FDA's CDER, CDRH, CBER and the Office of Regulatory Affairs — plus, other outstanding industry leaders to discuss, debate and dissect the latest priorities, expectations and best practices. During two-and-a-half intensive days, you'll participate in rigorous workshops that focus entirely on the latest inspection strategies. Plus you'll listen to keynote presentations by current and former FDA officials and experts. There are three specialized tracks to choose from — drugs/biologics, devices and clinical trials.
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| PUBLISHER'S NOTE:Some of the news agencies sourced within the Manufacturing World Roundup section may require subscriptions to access their information. At the time of transmission, all links to news articles functioned, but FDAnews cannot guarantee the accuracy of the information or that the listed news agencies will not move or delete information. |
