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warning letter 11 articles

FDA barred from inspecting China drug manufacturing company

Last November, Food and Drug Administration (FDA) investigators peeped into the windows of a warehouse at Beijing Taiyang Pharmaceutical Industry Co. Ltd., in China and spotted numerous drums bearing the company’s label. But when investigators asked to access the warehouse, employees “barred them from entering … without a reasonable explanation.” The following day, the company gave the investigators access to the warehouse. “However, upon entry they spotted that a number of the drums had been removed and were not available for inspection. When they asked about the drums they had observed the previous day, (employees) provided no explanation of the ... Read More

E-Cigarette retailers Receive Warning Letters From the FDA Over Selling to Minors

Recently the U.S. Food and Drug Administration (FDA) handed out warning letters to five companies that sell e-cigarettes, citing them for selling their products to minors. Since new regulations have been placed on e-cigarette marketing and sales, the vaping community and sellers have been reacting with fierce opposition. Rounds of warning letters have already been sent out from the FDA to e-cigarette sellers for products sold to minors, and now five more companies – iPuffVapor, Puff n Stuff Kissimmee Inc., Encore Vapor Inc., Mission Pipe Cigar Shop and Rize Vapor – have been recipients of the letters. As of the end of September, a ... Read More

FDA cracking down on companies selling products claiming to prevent, treat or cure head injuries

Some manufacturers of dietary supplements are trying to capitalize on the public’s rising concern over the seriousness of concussions, and are making false and dangerous claims that their products can prevent, treat or even cure brain injuries. Even if a supplement contained no harmful ingredients, that claim alone can be dangerous, says Gary Coody, National Health Fraud Coordinator with the Food and Drug Administration (FDA). The FDA is clamping down on drugs that make such claims, sending warning letters to the companies that manufacture the supplements and warning the public to avoid the products because their claims are not backed ... Read More

FDA launches program to stop importation of dangerous, ineffective drugs

The Food and Drug Administration (FDA) has implemented a new pilot program designed to crack down on the import of contaminated, misbranded or unapproved drugs into the United States. The Secure Supply Chain Pilot Program will help ensure the safety of drugs manufactured outside the country, but will also help qualified drug companies in the program by expediting their approval processes so that the agency can focus on drugs not in the program that may need closer inspection to ensure safety. In order to qualify to be in the program, pharmaceutical companies must be the sponsor of a New Drug ... Read More

Fresenius receives FDA warning letter claiming violations of good manufacturing practices

Fresenius Kabi Oncology, maker of generic intravenous oncology drugs, has received a warning letter from the Food and Drug Administration (FDA) citing manufacturing violations at the firm’s Kalyani facility in West Bengal. The letter says that an inspection of the facility last January found significant deviations from current good manufacturing practice for the manufacture of active pharmaceutical ingredients. Fresenius Kabi sent a response a month later, which the FDA says lacks sufficient corrective actions. The agency claims Fresenius Kabi kept samples, data and results outside the local systems for assessing quality, which raised serious concerns regarding the integrity and reliability ... Read More

Fresenius receives FDA warning letter regarding another dialysis product

Fresenius Medical Care North America, a division of Fresenius Medical Care, the world’s largest provider of dialysis products and services, received a warning letter from the Food and Drug Administration (FDA) alleging the company’s Optiflux Polysulfone Dialyzers, a dialysis product, did not go through adequate design verification studies and thus the products are considered unadulterated. The Optifulx Polysulfone is like an artificial kidney. It is used during hemodialysis to process blood and remove molecules that would otherwise build up when the kidneys are not functioning normally. The devices are the No. 1 prescribed dialyzer brand in the country. The FDA ... Read More

Researchers study abnormal heart rhythm, sudden cardiac death among dialysis patients

A group of researchers from the University of Cincinnati is hoping that an implantable device can identify undetected heart rhythm abnormalities in patients undergoing hemodialysis. These patients are at high risk for sudden cardiac death, which doctors say may be linked to large shifts in electrolytes and volume in the blood during regular dialysis sessions. The study could help establish a link between heart rhythm abnormalities and different electrolyte levels in patients’ blood and in the solution used during dialysis. People with end-stage renal disease rely on dialysis to replace kidney function. The process involves a machine that filters waste ... Read More

Practices at pharmacy in meningitis investigation were cited six years ago

The compounding pharmacy that made and distributed the injectable steroid that may be the source of a deadly outbreak of fungal meningitis was investigated by state public health officials in January 2006 for complaints made to the Food and Drug Administration (FDA) involving the same steroid. Compounding pharmacies use FDA-approved medications from pharmaceuticals manufacturers to remix and customize prescriptions for patients, doctors and health care facilities. These pharmacies are not regulated by the FDA. Oversight is left to state agencies. However, in 2006 the FDA issued a warning letter to Massachusetts-based New England Compounding Center (NECC) highlighting several alleged violations. The ... Read More

Unsanitary conditions, dangerous bacteria found at Kellogg cookie plant

Unsanitary conditions and an illness-causing bacteria were found in an Augusta, Ga., Kellogg’s plant where Keebler and other cookies are made, according to the Food and Drug Administration (FDA). Listeria monocytogenes was discovered at the plant in and around the production-line conveyor belts, pooling water was seen dripping into an open mixer bowl, and flies were spotted buzzing near food mixers. Listeria is a food borne pathogen that is responsible for about 2,500 illnesses and 500 deaths in the United States each year. It is considered more deadly than other food borne pathogens, such as Salmonella and botulism. The bacteria ... Read More

Salix stock soars despite FDA warning letter

Salix Pharmaceuticals stock rose 5 percent last week despite news that the company received a warning letter from the Food and Drug Administration (FDA) urging the company to clarify information about its new orally dissolving heartburn treatment, Metozolv ODT, according to Local Tech Wire. The FDA said that some of the drug’s marketing materials are “false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims.” Salix received FDA approval for Metozolv last September, offering an alternative to the metoclopramide pill known by the brand name Reglan. Reglan ... Read More