Teva Pharmaceuticals Warning Letter from FDA
FDA Sent Warning Letter To Teva Pharmaceuticals Industries. The U.S. Food and Drug Administration (FDA) has sent a warning letter to Teva Pharmaceutical Industries Ltd on October 14, 2016. The warning letter is associated with an FDA Current Good Manufacturing Practices (CGMP) inspection of Teva's manufacturing facility. The FDA … [Read more...]
Skincare Company gets FDA Warning Letter
Skincare Company Selling Unapproved Drugs. A warning letter was issued by the U.S. Food and Drug Administration (FDA) to a skincare company for promoting and selling unapproved new drugs. Whether at the District Office level or at Headquarters, the FDA will take steps against products promoted with unproven claims about a new product … [Read more...]
Unsafe Lime Crime Lipstick Ingredients Prompt FDA Warning Letter
Unsafe Lipstick Ingredients On Lime Crime's Lipstick. After learning about unsafe ingredients listed on the label of Lime Crime's Velvetines Liquid Matte Lipstick, the Food and Drug Administration (FDA) sent the company a warning letter directing it to correct the violations. The letter, dated July 29, warns Lime Crime that the … [Read more...]
L’Oreal Warned by FDA for Improper Marketing
FDA Warning Letter To L’Oreal Marketing. The U.S. Food and Drug Administration (FDA) has issued a February 12 warning letter to L'Oreal for the improper marketing of its Rosaliac AR Intense and Mela-D Pigment Control. According to Regulatory Affairs Professionals Society (RAPS), the agency said these products are being marketed as … [Read more...]
FDA Warning Letter Issued over Visipaque Web Site
FDA Warning Letter For Visipaque. GE Healhcare is in trouble with the U.S. Food & Drug Administration (FDA) over a Web site for its imaging drug, Visipaque. The agency issued GE a warning letter on January 7, saying the Visipaque Web site is misleading, and omits information about the drug's risks. Visipaque is used with … [Read more...]
FDA Warning Letter On German Plant
Warning Letter On Bayer German Plant. Following an inspection in March that caused the U.S. Food and Drug Administration (FDA) concern regarding Bayer AG’s ability to test and monitor quality, a warning was issued to the pharmaceutical giant. Reuters wrote that the issue concerned testing at Bayer’s Bergkamen, Germany facility, … [Read more...]
Genzyme Hit With FDA Warning Letter
Genzyme Received FDA Warning Letter. Biotech giant, Genzyme Corporation, has received a warning letter over what federal regulators are describing as “significant objectionable conditions” at its Boston manufacturing plant, reports the Boston Business Journal. The conditions were so problematic that the regulators are threatening … [Read more...]
Merck’s Manufacturing Problems at Gardasil Factory May be Easing
Manufacturing Problems In Gardasil Vaccine Operations. Not too long ago, Merck received a Food & Drug Administration (FDA) warning letter citing good manufacturing practice violations at its vaccine operations in West Point, Pennsylvania following an inspection that cited 49 Form 483 observations. Among the products made at the … [Read more...]
FDA Issues Chinese Heparin Supplier Warning Letter After Unsuitable Conditions
FDA Issues Chinese Heparin Supplier Warning Letter. An inspection by U.S. regulators of the Chinese factory that supplied tainted heparin ingredients to Baxter International revealed significant deviations from U.S. Current Good Manufacturing Practice standards. As a result, the Food & Drug Administration (FDA) informed the … [Read more...]
Stryker Hip Implant Recall, Warning Letters Point to Serious Problems
Concerns For Stryker Hip Implant Growing. The FDA decided to take a hard look at Stryker after receiving an unusually high number of complaints from recipients of Stryker hip implants. Since 2005, Styker hip implant patients have reported a range of problems, including pain, difficulty walking and “squeaky” joints, and some have had … [Read more...]
Stryker Trident Hip Implant Component Recall Latest Bad News
Stryker Trident Hip Implant Are Being Recalled. Stryker Hip Implant components, made under the company’s popular Trident line, are being recalled today, just months after Stryker Corp. received a Food & Drug Administration (FDA) warning letter about poor conditions at the Stryker plant in Mahwah, New. While the Stryker Hip … [Read more...]
Stryker Warning Letter Cites Contamination at Hip Replacement Plant
Bacterial contamination Issues Gets Stryker Warning Letter. Stryker Corp., a maker of hip and other joint replacement components, has received a second warning from the Food & Drug Administration (FDA) to correct bacterial contamination issues and other problems at its New Jersey manufacturing facility. In a warning letter dated … [Read more...]
FDA Warns Bausch & Lomb on Contact Lens Solution Linked to Infections
Bausch & Lomb Contact Lens Solution Infections. Bausch & Lomb Inc. failed to formally report nearly three dozen foreign cases of fungal eye infections later linked to one of its contact lens solutions, according to a federal warning letter. Bausch & Lomb didn’t report the 35 serious injury reports by April 7, as … [Read more...]
Bausch & Lomb Receives FDA Warning Letter
Bausch & Lomb Received A Warning Letter From The FDA. Bausch & Lomb (NYSE: BOL) today announced that it has received a Warning Letter from the United States Food and Drug Administration relating to an inspection the agency conducted at the Company’s Greenville, S.C. solutions manufacturing plant during the period March 22 through May … [Read more...]
Bausch Lomb Warning Letter
Bausch & Lomb Warning Letter From The FDA. Department of Health and Human Services' logoDepartment of Health and Human Services Public Health Service Food and Drug Administration Atlanta District Office 60 8th Street, N.E. Atlanta, Georgia 30309 October 31, 2006 VIA FEDERAL EXPRESS WARNING … [Read more...]
Boston Scientific Shares Dip on Letter News
Regulatory Problems In Medical Devices Shipped From Quincy, Mass. Federal regulators sent Boston Scientific Corp. a warning letter identifying "serious regulatory problems" in medical devices shipped from a Quincy, Mass., distribution plant, including heart stents sent to hospitals despite a quality control problem. The U.S.Food … [Read more...]
Off-Label Crestor Use Warning Letter
Astrazeneca Warning Letter To Physicians. AstraZeneca Plc issued a warning letter to British physicians regarding off-label prescribing of its statin Crestor (rosuvastatin), Reuters reported. After discovering four cases of rhabdomyolysis a muscle toxicity condition that can lead to kidney damage among high-dose Crestor users, the … [Read more...]
FDA Sends Warning Letter To Vioxx Maker
Vioxx Maker Misleading Information. The Food and Drug Administration has ordered Merck, maker of the blockbuster painkiller Vioxx, to issue a letter to doctors "to correct false or misleading impressions and information" stemming from the drug's promotional campaign. Merck's marketing efforts, aimed mainly at doctors, have … [Read more...]
