Topway Enterprises DBA Kazy’s Gourmet, of Houston, Texas, Food Facility Registration Suspeneded By FDA

The U.S. Food and Drug Administration today announced it has recently suspended the food facility registration of Topway Enterprises Inc., also doing business as Kazy’s Gourmet, of Houston, Texas. Topway now cannot sell or distribute any food into commerce. This action follows inspections conducted by the FDA and Texas Department of State Health Services (DSHS) earlier this year where serious sanitation issues were observed, including several samples confirming the presence of Listeria and pathogenic Listeria monocytogenes (L. monocytogenes).

The company has yet to implement adequate corrective actions at their facility and as a result the FDA-issued safety alert on July 18. The alert advises restaurants and food retailers in Texas and Louisiana to stop selling and discard recent shipments of Topway’s ready to eat (RTE) seafood products, including raw tuna and salmon, due to possible Listeria contamination. This is the sixth time the FDA has suspended a facility’s registration since receiving the authority under the FDA Food Safety Modernization Act.

“The FDA and the Texas DSHS have documented a pattern of food safety violations at the Topway facility as well as an unwillingness and disregard by the company to cease operations and correct severe violations at their facility. Topway’s unsafe practices not only violated the law, but also jeopardized the health of consumers as the company continued to knowingly distribute food products likely to be contaminated with Listeriafor public consumption,” said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas.

In addition to advising restaurants and food retailers to stop selling Topway’s RTE seafood products, the FDA safety alert specifically advises consumers who have recently purchased RTE seafood products in Texas and Louisiana, particularly salmon and tuna for raw consumption, to contact the restaurant or food retailer for more information about where the seafood was processed and sourced. Topway ships RTE fresh seafood products to restaurants and food retail outlets. Consumers who think they have purchased or consumed Topway products should discard products.

L. monocytogenes a species of disease-causing bacteria. When people eat food contaminated with L. monocytogenes, they may develop a disease called listeriosis. This infection can have serious adverse effects for consumers, particularly women who are or may become pregnant, the elderly, and people with weakened immune systems. Therefore, the FDA continues to advise that recipients of Topway RTE seafood products, clean and sanitize the surfaces on which these products were served, stored or prepared.

The FDA first inspected the Topway facility in February, which resulted in the detection of 31 non-pathogenic Listeria on swabs collected throughout the facility and observations of egregious sanitation deficiencies. At the close of the inspection, the investigators issued a FDA Form 483 to document inspectional observations pertaining to insanitary conditions at the facility. The form noted poor employee sanitation and production practices and significant facility deficiencies, such as cracked and uncleanable floors in the high-traffic areas such as the production and fish cooler rooms, pools of black water on the fish cooler floors, uncleaned utensils used to process seafood, fish particles on production room walls, and an accumulation of residues on seafood processing tables. The FDA alerted Topway of the agency’s findings and the company assured the agency it would take corrective actions.

On behalf of the FDA, the Texas DSHS conducted a follow-up compliance inspection from June 24 through July 3. State inspectors observed that the company had not corrected the sanitation and seafood safety compliance deficiencies identified by the related FDA inspection. This inspection resulted in 66 non-pathogenic Listeria positive samples, egregious sanitation deficiency observations and four environmental swabs that tested positive for L. monocytogenes.

On July 3, FDA and Texas officials notified Topway of the recent environmental sampling results for their facility. The company agreed to voluntarily cease operations and recall certain products. To date, the company has not implemented adequate corrective actions to address the risks that were identified. Topway also continued production by operating in a temporary location where it moved some equipment and personnel to process seafood products for sale while performing cleaning at its facility.

The FDA is in the process of working with the company to address the violations at both locations. Only after an appropriate corrective plan has been established and implemented at both the facility and temporary processing location will the FDA consider allowing the company to resume operations.

The FDA is not aware of any confirmed illnesses related to these seafood products. However, consumers who think they may have been sickened by these products should seek the assistance of a health care professional and contact the FDA to report problems with any FDA-regulated products.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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U.S. Grown Jalapeño and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak

FOR IMMEDIATE RELEASE Statement July 25, 2008

Media Inquiries: Michael Herndon, 301- 827-9182 Consumer Inquiries: 888-INFO-FDA

U.S. Grown Jalapeño and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak

The U.S. Food and Drug Administration is advising consumers that jalapeño and Serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak.

However, the FDA continues to advise consumers to avoid raw jalapeño peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico.

In addition to domestically grown raw jalapeño peppers, commercially canned, pickled and cooked jalapeño peppers from any and all geographic locations also are not connected with the current Salmonella Saintpaul outbreak.

The FDA is working with state regulatory agencies and food industry groups that represent restaurants, grocery stores and wholesalers to ensure everyone clearly understands this new, more narrow, advisory. The FDA will continue to refine its consumer guidance as the agency’s investigation continues.

The more narrow advisory the FDA is issuing today is based on evidence gathered during a multi-week, intensive investigation conducted in partnership with the U.S. Centers for Disease Control and Prevention and public health authorities in several U.S. states to find the source of the contamination that led to the outbreak. The collective review of the current traceback investigation and harvesting dates, matched with the dates that people became ill, have combined to indicate that the contaminated jalapeño pepper originated in Mexico.

Additional traceback and traceforward information obtained this week has led to the determination that the Agricola Zarigoza produce-distribution center in McAllen, Texas--from where FDA took the positive jalapeño pepper sample--was not the original source of the contamination.

The FDA is continuing to advise that people in high-risk populations, such as elderly persons, infants and people with impaired immune systems, avoid eating raw Serrano peppers from Mexico or food made from raw Serrano peppers from Mexico until further notice.

Tags: FDA News, Jalapeño and Serrano Peppers, Salmonella Saintpaul Outbreak

FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.

FOR IMMEDIATE RELEASE May 16, 2008

Media Inquiries: Rita Chappelle, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.
Company manufactures and distributes unapproved and adulterated drugs

The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products. The government's complaint, filed by the U.S. Department of Justice, alleged violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements (CGMP).

"The FDA will not allow a company to put the public's health at risk," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks."

The unapproved new drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.

The FDA had warned Scientific Laboratories against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures.

"The FDA will take action against companies and their executives who violate the law and endanger public health," said Margaret O'K. Glavin, associate commissioner for Regulatory Affairs. "The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs."

The consent decree bars the defendants from manufacturing and distributing any drug until they obtain required FDA approval and fully comply with CGMP requirements. The defendants must destroy their illegal drugs. The consent decree also allows the FDA to order the defendants to shut down in the event of future violations. It also subjects the defendants to liquidated damages in the amount of $5,000 per day if they fail to comply with any of the provisions of the decree, and an additional sum of $5,000 for each violation, up to $1 million per year.

If patients have these products in their homes, they should discuss with their health care provider whether to discontinue use of the products and to find alternative therapy. Pharmacies should discontinue dispensing these products.

In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs—Compliance Policy Guide" (CPG). This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective. The CPG also explains that FDA may take action against manufacturers and marketers of unapproved drugs that violate other provisions of the FD&C Act, including CGMP requirements.

The decree was signed Thurs., May 8, 2008 by Judge William D. Quarles, Jr., in the U.S. District Court for the District of Maryland.

Tags: FDA Regulations, FDA News, Scientific Laboratories, Inc

FDA Issues Regulation on Animal Feeds with Added Safeguards Against BSE "mad cow disease",

FDA Strengthens Safeguards for Consumers of Beef
Issues Regulation on Animal Feeds with Added Safeguards Against BSE

The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as "mad cow disease").

"This FDA action serves to further protect the U.S. cattle population from the already low risk of BSE," said Dr. Bernadette Dunham, Director of FDA's Center for Veterinary Medicine. "The new rule strengthens existing safeguards."

The new measure builds on FDA's 1997 feed regulation, which prohibited the use of certain mammalian proteins in ruminant feed.

The materials that can no longer be used in animal feed are the tissues that have the highest risk for carrying the agent thought to cause BSE. These high risk cattle materials are the brains and spinal cords from cattle 30 months of age and older. The entire carcass of cattle not inspected and passed for human consumption is also prohibited, unless the cattle are less than 30 months of age, or the brains and spinal cords have been removed. The risk of BSE in cattle less than 30 months of age is considered to be exceedingly low.

The removal of high-risk materials from all animal feed will further protect against inadvertent transmission of the agent thought to cause BSE, which could occur through cross-contamination of ruminant feed (intended for animals with four-chambered stomachs, such as cattle) with non-ruminant feed or feed ingredients during manufacture and transport, or through misfeeding of non-ruminant feed to ruminants on the farm. The added measure of excluding high-risk materials from all animal feeds prevents any accidental feeding of such ingredients to cattle.

Today's regulation finalizes a proposed rule that the FDA issued for public comment in October 2005. The final rule is effective 12 months from today to allow the livestock, meat, rendering, and feed industries time to adapt their practices to comply with the new regulation. Under the new requirements of the final rule, renderers that process cattle not inspected and passed for human consumption must make available for FDA inspection their written protocols for determining the age of cattle and demonstrating that the brain and spinal cords of cattle have been effectively removed.

Scientific studies have linked BSE to cases of variant Creutzfeldt-Jakob Disease (vCJD) in humans, an invariably fatal disease that most likely results from human consumption of infectious material from cattle with BSE. Rules issued in 2004 prohibited specified risk materials from use in the human food supply. There have been no vCJD cases linked to consumption of U.S. beef and the risk of BSE among U.S. cattle is low.

FDA regulates animal feed and drugs. The U.S. Department of Agriculture (USDA) and FDA promulgate and enforce the regulations that ensure the exclusion of specific risk materials from the human food supply.
tag: FDA, FDA News, BSE, FDA Regulations, mad cow disease, mammalian protein, 1997 feed regulation, four-chambered stomachs, Creutzfeldt-Jakob Disease