Inspections, Compliance, Enforcement, and Criminal Investigations
Center for Food Safety and Applied Nutrition (Cont.) 2002
Center for Food Safety and Applied Nutrition (Cont.)
Frozen Snapper Fillets with Salmonella
FDA Analysis Finds Salmonella
On August 2, 2002, FDA’s Miami Imports Resident Post collected a sample of Frozen Snapper Fillets distributed by PT Dharma Samudera Fishing Ind., Jakarta, Indonesia. On August 14, 2002, analysis by FDA’s Southeast Regional Laboratory found the sample to be positive for Salmonella. The entry consisted of 2,800 master cartons, with a total weight of 18,780 kilograms (approximately 41,402 pounds), valued at $117,890. The shipment was refused entry.
Dried Peppers and Smelt Fish Destroyed
On August 13, 2002, an investigator from FDA’s Chicago District Office witnessed the destruction of 996 cartons of dry peppers and 15 cartons of dry smelt fish at Lydia Macias Company, Chicago, Illinois. The products had been imported from Products Y Similes Macias, Mexico, and valued at $21,847. The products were refused entry because they were found to be filthy.
Jarred Vegetables Refused Entry
On August 12, 2002, FDA’s Chicago District Office investigators witnessed the destruction of about 443 cartons of various jarred vegetable products, valued at $6,520. The products had been refused entry after FDA examination revealed the products to be low-acid canned foods for which no processes have been approved. Also destroyed were 100 cartons of lollipops, valued at $1,170, that were refused entry for labeling violations including failure to bear English labeling and nutrition labeling. The products originated from Astra Spolka of Jaslo, Poland, and were imported by Lowell International of Rolling Meadows, Illinois.
Liquidated Damages Paid
FDA’s New York District Office was notified by the U.S. Customs Service, Fines, Penalties & Forfeitures Division, Buffalo, New York, of the collection of over $28,000 in liquidated damages paid from FDA cases covered by the Port of Buffalo. The amount was collected for failure to redeliver merchandise refused admission and the exportation of merchandise without proper supervision from various liquidated damages cases and failure to hold FDA- regulated merchandise intact prior to entry review. The amount included $8,419 in liquidated damages paid by Rich Products Corporation, Buffalo, New York, for failure to hold an entry of bakery products intact.
Dried Pigeon Peas Refused Entry
FDA Lab Finds Prohibited Pesticide in Dried Pigeon Peas On April 18, 2002, FDA’s San Juan District Office collected a sample of dried pigeon peas, valued at $13,901.00, that was imported by Quintana Hermanos, Inc., San Juan, Puerto Rico, and manufactured by Procesadora SAC, Lima, Peru. FDA’s Southeast Regional Laboratory analysis of the peas found the product to contain Chlorpyrifos, a pesticide that is not allowed for this commodity. The product was detained and subsequently refused entry.
Mushrooms with Pesticides Refused Entry
FDA’s Baltimore District Office issued Notices of Refusal of Admission on August 2, 2002, for five entries of mushrooms, valued at $197,400.00, due to the presence of pesticides. The importer was Kanan Foods, Oakbrook Terrace, Illinois. The manufacturer was Agro Dutch Foods, India.
Warning Letter Issued to Importer
FDA’s San Francisco District Office issued a Warning Letter to Linma International, Inc., of Burlingame, California. The firm imports aquacultured shrimp. An FDA inspection conducted on November 14 and 16, 2001, disclosed that the firm's product specifications did not address the food safety hazard of aquaculture drugs, and the foreign processor's HACCP plan did not list this hazard as well. The Warning Letter noted that “...nine months have elapsed since FDA inspection. You have had sufficient time to correct the violations.
Failure to Hold Product Results in Warning Letter
On May 8, 2002, FDA’s Florida District Office issued a Warning Letter to the president of Lamar Seafood Corporation, Miami, Florida, for failure to hold an entry of fresh crab meat intact at the port of entry pending FDA release. Previously, on April 2, 2002, FDA attempted to examine a shipment of fresh crabmeat. The shipment was partially unavailable for FDA examination because the product had been partially distributed. Per the firm’s request, FDA investigators visited the firm on April 10, 2002, to conduct an examination of the lot, including the amount of product redelivered to the firm. FDA examination revealed that the firm was not successful in redelivery of the crabmeat under this entry. FDA requested that U.S. Customs Service order redelivery of the crabmeat.
FDA Witnesses Destruction of Decomposed Seafood
Crawfish Stored at 48 Degrees F Show Evidence of Decomposition On May 21, 2002, FDA’s Chicago District Office witnessed the destruction of decomposed seafood ["fresh" langoustines]. FDA's examination of the crawfish like product revealed an internal temperature of 48 degrees F, plus visible and odiferous evidence of decomposition, including mushy and discolored flesh. The product was part of a shipment valued at more than $4,000 that originated from Dayseaday B.V. in the Netherlands, and was imported by The Plitt Company, Chicago, Illinois.
FDA Issues Health Alert for Powdered Infant Formula
FDA and CDC Link Exposure to
On April 12, 2002, FDA alerted health care professionals about the risk of Enterobacter sakazakii (E.sakazakii) infections in hospitalized newborn infants, particularly premature infants or other immuno-compromised infants fed powdered infant formulas. This alert issued by FDA was targeted to concerns for immuno-compromised infants in hospital settings. FDA was not aware of E. sakazakii infections among healthy full-term infants in home settings. In addition, this alert did not involve the use of liquid infant formulas.
E. sakazakii is an emerging food borne pathogen that can cause sepsis, meningitis, or necrotizing enterocolitis in newborn infants, particularly premature infants or other infants with weakened immune systems. Over the last several years, investigations of several outbreaks of E. sakazakii infection occurring in neonatal intensive care units worldwide have shown the outbreak to be associated with milk-based powdered infant formulas.
The U. S. Centers for Disease Control and Prevention (CDC) investigated a fatal E. sakazakii meningitis case in a neonatal intensive care unit in the United States. According to the CDC, the use of milk-based powdered formula was a likely factor in the infection of this infant. The details of CDC's investigation is outlined in an edition of the Morbidity and Mortality Weekly Report (MMWR). As part of their investigation, CDC performed a survey on all 49 infants in the neonatal intensive care unit and intermediate nursery during April 10 - 20, 2001.
CDC colonized Enterobacter sakazakii from nine infants. Forty infants had no infection. One 11 day old male who was already seriously ill acquired Enterobacter sakazakii meningitis and died. Two infants exhibited respiratory distress, one infant had genitourinary symptoms but recovered, and the remaining five cases showed no symptoms. Comparing cases to non cases, only exposure to powdered formula was a significant risk factor. Cultures from both opened and unopened cans of powdered formula were later found positive at very low levels for E. sakazakii by CDC. Testing of the suspect lot of infant formula by an outside laboratory for Mead Johnson using the release testing methodology, and by the hospital, was negative for Enterobacteriaceae.
FDA issued a letter to health professionals which provided recommendations for minimizing the risk in those circumstances when a powdered infant formula must be used for premature or immuno- compromised infants.
FDA urged health care providers to report adverse events associated with the use of infant formulas as soon as possible to FDA's MedWatch program by calling their toll-free number (1-800-332-1088) or through the Internet. Healthcare providers were advised that they should report invasive disease in infants due to E. sakazakii, particularly bloodstream infection or meningitis with onset in the healthcare setting, to CDC's Division of Healthcare Quality Promotion (1-800-893-0485). FDA and CDC continue their efforts to prevent E. sakazakii infections associated with powdered infant formula.
In a letter providing background information for health professionals, FDA pointed out that powdered infant formulas are not commercially sterile products. Powdered milk-based infant formulas are heat-treated during processing, but unlike liquid infant formula products they are not subjected to high temperatures for sufficient time to make the final packaged product commercially sterile.
FDA noted that infant formulas nutritionally designed for consumption by premature or low birth weight infants are available only in commercially sterile liquid form. However, so-called "transition" infant formulas that are generally used for premature or low birth weight infants after hospital discharge are available in both non-commercially sterile powdered form and commercially sterile liquid form. Some other specialty infant formulas are only available in powdered form.
The letter further stated that, “In light of the epidemiological findings and the fact that powdered infant formulas are not commercially sterile products, FDA recommends that powdered infant formulas not be used in neonatal intensive care settings unless there is no alternative available.” If the only option available to address the nutritional needs of a particular infant is a powdered formula, risks of infection can be reduced by:
- Reconstituting powdered formula using boiling water with subsequent refrigeration before feeding, recognizing that some loss of certain water soluble vitamins (e.g., thiamin, ascorbic acid) is likely to occur;
- Preparing only a small amount of reconstituted formula for each feeding to reduce the quantity and time that the formula is held at room temperature for consumption;
- Minimizing the holding time, whether at room temperature or while under refrigeration, before a reconstituted formula is fed; and
- Minimizing the "hang-time" (i.e., the amount of time a formula is at room temperature in the feeding bag and accompanying lines during enteral tube feeding), with no "hang-time" exceeding 4 hours. Longer times should be avoided because of the potential for significant microbial growth in reconstituted infant formula.
Portagen Recalls Powdered Infant Formula
Firm Recalls Powdered Infant
On March 29, 2002, Mead Johnson Nutritionals, Evansville, Indiana, issued a Press Release stating that “...in keeping with their commitment to provide safe and healthy nutritional products, the firm was recalling one batch of Portagen powder.” Portagen powder is a nutritional product for adults, toddlers and infants with rare digestive diseases that prevent them from digesting or absorbing fats. Portagen is intended for use under a physician's supervision and is not typically available at retail stores. The batch, coded BMC17, with an expiration date of January 2003, was in national distribution and first shipped to distributors and hospitals in February 2001. Any cans from this shipment should not be used. No other batches of Portagen product were involved.
The Press Release stated that, “The recall was initiated after a report that a premature infant died in April 2001, of a rare form of meningitis caused by the bacteria Enterobacter sakazakii. The child reportedly became ill after being tube-fed Portagen from this batch.”
The firm stated that, “Mead Johnson wants to assure consumers that all of our products are manufactured with strict adherence to the highest standards, using high quality ingredients. The microbiological quality of each batch of Portagen is assessed using validated methods, and our product specifications are consistent with those proposed by FDA and other U.S. regulatory organizations.” The recall number for this Class I recall is F-421-2.
Seizure at Kar Nut Products
Firm Continued to Market Nuts with Unauthorized Health Claims Despite FDA Warning Letter
Despite FDA Warning Letter On May 7, 2002, an FDA investigator accompanied the U.S. Marshals Service to conduct a seizure of misbranded nut products at Kar Nut Products, Ferndale, Michigan. The firm continued to misbrand their nut products with unauthorized health claims despite receiving a Warning Letter. The products were distributed nationwide through vending machines and convenience stores. The open-ended seizure encompassed all products on hand that had unauthorized health claims. These claims linked the consumption of nuts to the reduction of blood cholesterol levels, body weight, and risk of heart disease by 50 percent or more. An FDA inspection conducted at the firm during January 30 and February 7, 2002, revealed approximately $94,000.00 worth of nut products on hand with the unauthorized claims. An inventory during the inspection also revealed in excess of 500,000 unused violative labels remaining at the firm. The retail value of the seized goods was approximately $37,000.00.
Recall of Cinnamon Quakes Crispy Rice Snacks
FDA’s Chicago District Office officials met with the representatives from The Quaker Oats company to discuss a recall of "Apple Cinnamon Quakes Crispy Rice Snacks." The suspect product was manufactured on February 13, 2002, in the Columbus, Missouri plant. The product contained dairy ingredients with no label declaring dairy. Consumers found Cheddar Cheese Quakes in the Apple Cinnamon Quakes bags. The firm stated that they identified the cause of the problem and had implemented corrective actions. The district monitored the recall to conclusion. The recall number for this Class I recall is F-455-2.
Undeclared Milk Product in Tomato Pies
Undeclared Romano Cheese
On July 11, 2002, Don Berto's Baking Co., Philadelphia, Pennsylvania, recalled 4,186 tomato pies following a report of an allergic reaction after consuming this product. People who have an allergy or severe sensitivity to milk run the risk of serious or a life threatening allergic reaction if they consume the product. The tomato pies were distributed to Pennsylvania, New Jersey, Delaware, Maryland. The recall number for this Class I recall is F-713-2.
Warning Letter Issued for Ready-to-Eat Seafood
Serious Deviations From HACCP
On May 6, 2002, FDA’s Chicago District Office issued a Warning Letter to Gung Ho corporation, Bellwood, Illinois, a manufacturer of Oriental Specialty Foods. An FDA inspection of the firm on March 19 and 21, 2002, disclosed serious deviations from the seafood hazard analysis and critical control point (HACCP) regulations. These deviations included failure to have a written HACCP plan to control any food safety hazards that are reasonably likely to occur for cooked, ready-to-eat, crab Rangoon. In addition, the firm did not have an adequately trained or qualified individual to adequately monitor instrument calibration records related to its ready- to-eat food operations. FDA decided to issue the Warning Letter when the firm did not satisfactorily resolve all of the district’s concerns.
Warning Letter Issued to Importer of Aquacultured Shrimp
On August 15, 2002, FDA’s San Francisco District Office issued a Warning Letter to Linma International, Inc., of Burlingame, California. The firm is an importer of aquacultured shrimp. FDA conducted an inspection on November 14 and 16, 2001. The inspection found that the firm's product specifications did not address the food safety hazard of aquaculture drugs that is reasonably likely to be present in aquacultural-grown shrimp. In addition, the firm’s foreign processor’s HACCP plan did not list the food safety hazard of aquaculture drugs.
Firm Fails to Have an Adequate HACCP Plan
FDA Inspection Finds Firm Has No
On April 26, 2002, FDA’s Florida District Office issued a Warning Letter to R.H.V., Inc., d/b/a Villers Seafood, Ft. Myers, Florida. Investigators from the Florida District Office conducted an inspection of the firm in September 2001. This inspection disclosed serious deviations from the Seafood HACCP regulations. These deviations included the following: failure to have a HACCP plan that lists the actual critical control points and critical limits implemented by the firm; failure to have adequate monitoring procedures for each critical control point (for example, the firm’s HACCP plan for fresh shrimp did not list any monitoring procedures to control the hazard of sulfites); and failure to retain monitoring records at the processing facility.
Warning Letter Issued to Firm for Deficiencies in HACCP for Crabs
On May 21, 2002, FDA’s Seattle District Office issued a Warning Letter to The Best Fish Company, LLC, d.b.a. Crab Fresh, Seattle, Washington. FDA inspected the firm on January 29, 30, and February 1, 2002. The inspection disclosed serious deviations from FDA regulations regarding Fish and Fishery Product. These deviations involved whole-cooked crab and refrigerated cooked crabmeat packed in vacuum-pulled metal cans.
The firm did not have a HACCP plan that lists food safety hazards that are reasonably likely to occur for cooked crabmeat in vacuum-pulled metal cans to address the hazard of Clostridium Botulinum. Other deviations included insufficient critical limits to control pathogen growth at the cooling and storage B critical control points (CCPs). The firm also failed to perform monitoring of critical limits at the cooking CCP; failed to have adequate monitoring procedures at the cooling and storage CCPs; and failed to have adequate sanitation monitoring. In addition, the firm failed to maintain written verification procedures, with a selected affirmative step and product specifications, for live Dungeness crabs imported from Canada.
Inadequate Controls to Prevent Histamine Formation
On July 30, 2002, FDA’s New Orleans District Office issued a Warning Letter to St. Vincent Seafood, Cut Off, Louisiana, for HACCP violations occurring at their Leeville, Louisiana plant. An inspection on May 10 and 14, 2002, revealed serious deviations for seafood HACCP regulations. These deviations included the following: failure to have a HACCP plan that lists critical limits that must be met at each critical control point; failure to implement the record keeping system listed in the firm’s HACCP plan; and failure to have an adequate HACCP plan that lists monitoring procedures for each critical control point.
Seafood Entree Manufacturer Receives Warning Letter
FDA Inspection Finds Insanitary
On May 20, 2002, FDA’s New Orleans District Office issued a Warning Letter to Bodin Foods, Inc., New Iberia, Louisiana, a seafood entrée manufacturer. Investigators from the New Orleans District conducted an inspection of the firm on February 7-8, 2002. This inspection revealed deviations from the HACCP regulations, along with several objectionable insanitary conditions. The firm’s HACCP plan did not list several hazards, including allergenic ingredients, pathogen growth/toxin formation, and undeclared sulfites. The HACCP plans also contained critical limits that were not adequate to control pathogen growth or toxin formation. In addition, employees did not take any precautions to eliminate sources of possible contamination. Food processing equipment contained brown residues from previous operations and flaking paint was on metal objects above the cooked product. FDA’s New Orleans District Office monitored the firm’s corrective actions.
Inadequate HACCP Plan for Frozen, Fresh, and Ready-to-Eat Seafood
On May 6, 2002, FDA’s Cincinnati District Office issued a Warning Letter to C. E. Foods, Cleveland, Ohio, for deviations from the seafood HACCP regulations. The district inspection conducted in February and March 2002, documented serious deviations from the seafood HACCP regulations. These deviations were for the firm's frozen, fresh, and ready-to-at seafood products, e.g., tuna, mahi mahi, salmon, and pasteurized canned crabmeat. These deficiencies included:
- The firms HACCP plan for precooked seafood product such as pasteurized canned crabmeat was not adequate to control the food safety hazards of pathogen growth and toxin formation.
- The firm failed to implement the monitoring listed in their HACCP plan.
- Corrective action was not taken when a lot of fresh tuna received on 2/13/02 was unfit for use.
- The firm did not maintaining adequate sanitation control records.
Warning Letter Issued to Catfish Processor
Warning Letter Issued for Insanitary Conditions, HACCP Deficiencies, And Failure to Declare Allergens
FDA’s New Orleans District Office issued a Warning Letter to the president of Pride of the South Catfish, Inc., Brooksville, Mississippi, on May 10, 2002. The letter was based upon findings noted during an inspection conducted November 29-30, 2001. The inspection revealed continuing HACCP and sanitation deficiencies. The firm’s HACCP plan for fully cooked, breaded catfish patties did not indicate the hazards of pathogen survival during the cooking process. In addition, the breaded catfish patties did not declare allergens such as wheat flour and soy protein. The Warning Letter also noted insanitary conditions in that the firm did not monitor hand washing/sanitizing facilities and was not monitoring the food packaging.
FDA Finds Listeria at Fish Processing Facility
On May 7, 2002, FDA’s San Francisco District Office issued a Warning Letter to the president of North Coast Fisheries, Inc., San Francisco, California, for serious deviations from the seafood HACCP regulations. FDA’s inspection of the firm in November/December 2001, found that the firm (1) did not record monitoring observations of scombroid species fish (temperature, signs of decomposition, and adequacy of ice) at the receiving CCP to control histamine formation; (2) did not adequately monitor sanitation conditions and practices during processing. For example, an employee was observed using the ice shovel stored in the processing room floor to scoop clean ice on top of processed fish without washing or sanitizing in between. FDA’s San Francisco District laboratory found Listeria monocytogenes in environmental swabs taken at the facility.
Warning Letter Issued for Mahi Mahi
On May 3, 2002, FDA’s Detroit District Office issued a Warning Letter to the CEO of Morey's Seafood International, Golden Valley, Minnesota. The Warning Letter was issued for seafood HACCP violations found during an inspection on October 21 - 24, 2001, of the firm’s facility in Detroit, Michigan. The firm was cited for continued failure to meet a number of critical requirements for histamine producing fish. For example, the firm failed to have a HACCP plan that lists the critical limits that must be met, to comply with 21 CFR §123.6(c)(3); failure to implement a record keeping system listed in the firm’s HACCP plan; failure to have a critical limit that must be met in order to comply with 21 CFR §123.6(c)(3); and failure to implement the monitoring procedures listed in the firm’s HACCP plan.
Crabmeat Processor Destroys Contaminated Lump Crabmeat
On November 28, 2001, FDA’s New Orleans District Office witnessed the voluntary destruction of 280 pounds of ready-to-eat lump crabmeat contaminated with E. coli. The product was manufactured by Seafood International, Inc., Breaux Bridge, Louisiana. FDA’s New Orleans District Office issued a cessation letter to the owner to the firm on October 30, 2001. (The firm had been operating under a Consent Decree of Permanent Injunction since December 10, 1998.)
Blue Ribbon Smoked Fish, Inc. Enjoined
Court Enjoins Firm for Inadequate HACCP Plans and Fish Product Contaminated with Listeria
United States v. Blue Ribbon Smoked Fish, Inc., et al. (E.D.N.Y.). On November 20, U.S. District Judge Charles P. Sifton granted FDA's motion for summary judgment to enjoin Blue Ribbon Smoked Fish, Inc., a fish processor located in Brooklyn, New York, from violating the adulteration provisions of the Act. The court found that Blue Ribbon and three of its officers had established inadequate Hazard Analysis Critical Control Point ("HACCP") plans in violation of 21 U.S.C. § 342(a)(4) and 21 C.F.R. § 123.6(g); processed their fish products under insanitary conditions in violation of 21 U.S.C. § 342(a)(4); and introduced fish products contaminated with Listeria Monocytogenes into interstate commerce in violation of 21 U.S.C. § 342(a)(1).
The court also denied the individual defendants' motion to dismiss the complaint against them, relying upon U.S. v. Park, 421 U.S. § 658 (1975) and U.S. v. Dotterweich, 320 U.S. 277 (1943), FDA cases that hold corporate officials liable for their company's compliance with the Act. Rejecting Blue Ribbon's defense that new management had alleviated the insanitary conditions, the court focused instead on defendants' lengthy history of violations in determining the need for the injunction. The court also held that defendants' HACCP plans were facially inadequate.
Blue Ribbon argued that Listeria Monocytogenes is not an "added substance" and does not ordinarily present a risk to health because it affects only some segments of the population. Blue Ribbon also argued that, if the court found L. mono. to be an added substance, FDA's zero-tolerance policy violates the Act. The court rejected these arguments, finding that: 1) Listeria Monocytogenes is an "added substance;" 2) Listeria Monocytogenes is "injurious to the health of significant populations of consumers;" and 3) FDA is not required to set a tolerance level for Listeria Monocytogenes. The court granted relief as requested by the government, recognizing that it was consonant with the legislative intent behind the Act: "[b]y keeping contaminated fish processed under conditions of filth off consumer's tables, this permanent injunction will serve that important purpose."
Shellfish from Uncertified Waters Destroyed
FDA’s New York District Office together with the New York State Department of Environmental Conservation ordered a supermarket to destroy illegal frozen shellfish under FDA supervision. FDA’s New York District Office met with a state trooper after notifying the New York Department of Environmental Conservation that a New York Supermarket, a retail store located in Elmhurst, New York, was selling frozen shellfish from uncertified waters. FDA witnessed the destruction of approximately 200 pounds of the illegal frozen shellfish from China. The store was issued $5,000 in fines with a court appearance. The shellfish was placed into a waste container and a worker poured bleach over the product.
Consent Decree of Permanent Injunction at Bay Gourmets, Inc.
United States v. Bay Gourmets, Inc., et al. (C.D. Cal.). On April 4, 2002, a U.S. District Judge entered a Consent Decree of Permanent Injunction against the above defendants, Bay Gourmets, Inc., Vernon, California. The decree perpetually enjoins the defendants from processing, packing, holding, and distributing any hot and cold smoked fishery product unless and until: (1) the defendants hire an outside expert to establish and implement an adequate written Hazard Analysis Critical Control Point (HACCP) plan as well as a Sanitation Standard Operation Procedure (SSOP), both of which must be submitted to, and approved by, FDA; (2) the defendants commission a scientific validation of the adequacy of the critical limits in the HACCP plan; (3) the defendants establish and implement ongoing verification procedures in the HACCP plan; (4) the defendants examine representative samples of each lot of vacuum packaged smoked fishery products on hand at the time the Decree is entered and destroy or recondition all products that do not contain an acceptable water phase salt level; and (5) FDA notifies the defendants in writing that they appear to be in compliance with the Decree and the regulations. The defendants are to pay the costs of FDA's supervisory activities under the Decree. The defendants are also permanently enjoined from causing the introduction into interstate commerce of adulterated food or causing food to become adulterated. The Decree provides FDA with letter shutdown and recall authority.
Consent Decree of Permanent Injunction Hope African Foodline and Seafood Supply
United States v. Hope African Foodline & Seafood Supply (E.D. La.). On August 23, 2002, a U.S. District Judge entered a Consent Decree of Permanent Injunction against Hope African Foodline & Seafood Supply ("Hope African"), a seafood processor located in New Orleans, Louisiana. The U.S. filed a Complaint for Injunctive Relief on October 4, 2001, and a Motion for Summary Judgment on June 13, 2002. The Complaint alleged that Hope African violated the Federal Food, Drug, and Cosmetic Act by introducing adulterated articles of food, namely dried smoked catfish, into interstate commerce.
The catfish was adulterated under 21 U.S.C. § 342(a)(4) in that it was prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. Hope African's failure to have and to implement an adequate Hazard Analysis Critical Control Point ("HACCP") plan rendered its dried smoked catfish adulterated. The Decree contains the standard provisions permitting letter shut down, reinspection authority, and reimbursement of inspection costs.
Eastern Seafoods Company of Chicago Signs Consent Decree of Permanent Injunction
On July 19, 2002, Eastern Seafoods Company of Chicago, Illinois, signed a consent decree of permanent injunction. The decree enjoins the firm from processing, holding, and distributing any scombrotoxin forming fish or fishery products. This legal action culminates four years of efforts by the district to bring this firm into compliance. It also represents the agency’s first successful injunction against a firm solely for the lack of a HACCP plan and monitoring records at receiving (to control the hazard of histamine), in the absence of any injuries, complaints, violative samples, or any other operational conditions that would render products injurious to health.
Basil Leaves Recalled Because of Possible Salmonella Contamination
On July 17, 2002, Spice World, Inc., of Orlando, Florida, announced that the firm was voluntarily recalling one ounce plastic bottles of Spice World brand basil leaves, because the product had the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illness such as arterial infections (i.e., infected aneurysm), and endocarditis and arthritis. The recall also included Roma Brand Basil. The recall number for this Class I recall is F 765-2.
Romaine Lettuce Associated with Outbreak of E. Coli
On July 29, 2002, FDA issued a warning [See Press Release P02-25] to consumers not to consume Spokane Produce brand romaine lettuce because the product was associated with an outbreak of E. coli O157:H7. The outbreak occurred in a cheerleading camp in Washington State in mid-July 2002. Twenty-nine individuals at the cheerleading camp were confirmed to have E. coli O157:H7. FDA urged consumers to throw out this product.
E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death. The latest reported illness associated with this outbreak was on July 19, 2002.
The romaine lettuce, which was sold under several different brand names, was known to be packaged in 5 pound bags labeled "Romaine Toss" and was distributed by Food Services of America, which in the past had also distributed this product to restaurants and institutions in Idaho, Montana, and Oregon. The product has a shelf life of two weeks. The romaine lettuce may also have been sold at retail establishments in various size packages.
This situation was discovered when many individuals at the camp became ill. FDA worked with the Spokane Regional Health District, Washington State Department of Agriculture, Washington State Department of Health and other agencies to determine the cause and scope of the problem.
Warning Letter Issued to Vessel Watering Point
FDA’s New Orleans District Office issued a Warning Letter to Bollinger Quick Repair, Inc., for conditions found during an inspection on November 27, 2001. The inspection was conducted at the firm’s watering point operations located at its shipyard in Harvey, Louisiana. The current inspection revealed that eight of the potable water outlets located on the same manifold as the non-potable water outlets were not identified for their intended use, and the potable water hydrants were not equipped with caps and keeper chains. The firm was given a "Provisional" classification as a result of this inspection.