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  5. Center for Food Safety and Applied Nutrition continued 2001
  1. Enforcement Story

Center for Food Safety and Applied Nutrition continued 2001

Center for Food Safety and Applied Nutrition continued 2001

Chapter 4

Last Update: August 07, 2003

Imports

Failure To Hold Product Results in Warning Letter

On May 24, 2001, the FDA's Chicago District Office issued a Warning Letter to the president of Daiei Trading, headquartered in College Point, New York. The Warning Letter addressed the failure of the related local facility, located in Bensenville, Illinois, to hold intact an import shipment of frozen flounder and frozen sardines which had been detained by district. The district issued a joint Notice of Refusal and Redelivery with the Chicago Custom's Office. The Warning Letter advised the firm's president that a recurrence might subject his firm to regulatory action or detention of future shipments of imported seafood products.

Snow Peas Presented for Destruction Not Original Entry

FDA Requests Redelivery of Original Shipment of Snow Peas

The FDA's Florida District Office issued a Warning Letter on August 21, 2001, to the owner of Agroaltos, S.A., Miami, Florida. FDA attempted to supervise the destruction of 4 previously refused entries of snow peas and found that the snow peas that were presented for destruction were not the original product and that the snow peas did not appear to be the products that were originally entered into the U.S. FDA advised the firm that the Agency recommended that U.S. Customs Service (Customs) require that future entries of food by the firm be held in secured storage. In addition, FDA requested that Customs order redelivery of these 4 shipments.

Decomposed Frozen Shrimp Detained

On July 30, 2001, the FDA's Florida District Office collected a sample of frozen peeled shrimp on distributed by Zhoushan Foreign Trade and Economy, Zhejiang, China. On August 2, 2001, the Southeast Regional Laboratory found the sample to be decomposed. In addition, the individual 5-lbs. bags did not bear any labeling. The entry consisted of 2092/20 pound master cartons with each carton containing 4 5-pound plastic bags, valued at $83,608. The entry was detained, and upon the importer's request, the entry was refused so that it could be sent back to the supplier.

Uneviscerated Seafood Destroyed 

The FDA's Chicago District Office import team witnessed the destruction of two seafood entries on July 12-13, 2001. The first shipment consisted of 15 cartons of dried Pollack from Korea and the second shipment consisted of 151 cartons of assorted smoked fish from the Philippines. Both entries had been detained and refused entry under Import Alert 16-74 for being uneviscerated. The shipments had a combined valued of $6,612.00.

Undeclared Mahi Mahi Seized

The FDA's Florida District Office investigated and documented an attempted substitution of 1,769 pounds of fresh mahi mahi valued at $3,573, which was imported from Ecuador by Pacific Ocean Seafood, Miami, Florida, on April 9, 2001. At the time of entry, the Importer declared the shipment to consist of fresh snapper, and no fresh mahi mahi was declared.

Examination at the Miami airport cargo site confirmed the shipment consisted of snapper and undeclared mahi mahi. Follow-up examination of this fish entry at Pacific Ocean's premises revealed the mahi mahi presented to FDA as the original undeclared product was from another shipment. The FDA's Florida District Office recommended that U.S. Customs Service (USCS) seize the entire shipment.

On May 1, 2001, USCS seized 14 boxes of fresh mahi mahi, which were the substitute fish presented as the original shipment and 8 boxes of fresh snapper from the original shipment. The total appraisal value for the seizure was calculated at $10,722. USCS also issued a Notice demanding redelivery of the 14 boxes of mahi mahi which were unlawfully imported under the original entry and which Pacific had already distributed by April 7, 2001. The mahi mahi and snapper seized by USCS were eventually destroyed under FDA supervision.

Interstate Conveyance

FDA Inspection Finds Inadequate Food Protection

Complaint of Insanitary Conditions Results in Warning Letter

The FDA's San Francisco District Office issued a Warning Letter to the CEO of Northwest Airlines, Inc., St. Paul, Minnesota. The FDA conducted an inspection on May 9 and 10, 2001, of Northwest Airline DC-10 aircraft, #US 1149 (Flight 354) at the San Francisco International Airport. The inspection revealed a lack of adequate food protection. The firm was placed on provisional status because the internal temperatures of the entrees delivered to the aircraft were above 50 degrees F. The FDA's San Francisco District Office inspected the aircraft in response to a complaint about filthy conditions and rancid smells.

Prepared Foods

Tuna Fish Sandwiches in Violation of the Act

Firm Has No HACCP Plan for Tuna Salad Sandwiches Inspection Finds Insanitary Conditions

The FDA's Seattle District Office issued a Warning Letter to the Owner of Inland Vending Expand-O-Systems, Boise, Idaho. The firm is a manufacturer of a wide variety of packaged sandwich and pudding products. An FDA inspection of the firm on July 17 - 18, 2001, revealed many sandwich and pudding products containing undeclared allergens on product labeling including undeclared milk and milk products, egg and egg products, wheat flour, clam broth, and soy products, as well as yellow # 5 and # 6.

The Warning Letter also cited the firm for lack of an HACCP plan for the tuna fish sandwiches to control the food safety hazard of histamine formation. In addition, the firm did not maintain sanitation control records for sanitation. The firm voluntarily recalled the improperly labeled products and produced new product labeling with complete ingredient listings for future production of their sandwich and pudding products.

Warning Letter Issued for High Protein Bars

On July 26, 2001, the FDA's New Jersey District Office issued a Warning Letter to R-Kane Products, Inc., Pennsauken, New Jersey. The company manufactures several products that they claim are "High Protein," such at FI-PRO-TEIN Bars, Tiny Meal Bars, and Gel-lit High Protein Gelatin Desserts. To qualify for the high protein claim, the products must contain a minimum of 10 grams of protein. The products cited in the Warning Letter were labeled to contain between 7-8 grams of protein.

Warning Letter Issued To Tuna Salad Sandwich Manufacturer

FDA Inspection Finds Firm Lacks HACCP Plan for Tuna Salad Sandwiches

On May 29, 2001, the FDA's New Orleans District Office issued a Warning Letter to PollmanÂ’s Bake Shop, Inc., Mobile, Alabama, based upon findings during an inspection conducted on April 16 - 18, 2001. The inspection revealed that the firm did not have a HACCP plan for its tuna salad sandwiches and did not maintain sanitation control records. In addition, numerous insanitary conditions and practices regarding their non-seafood sandwich operations were documented.

For example, employees working in direct contact with food and food-contact surfaces did not take necessary precautions to protect against contamination of those items with microorganisms or foreign substances. In addition, the sandwich assembly table surface, which was pitted and nicked, was encrusted with a black foreign material and the meat-cutting machine was encrusted with material from previous operations.

Breaded Fish with Macaroni and Cheese Dinner Recalled

Undeclared Egg Whites Results in Recall

On September 12, 2001, MC Retail Foods of Omaha, Neb., announced that they were recalling the 12-ounce packages of Marie Callender's Breaded Fish with Macaroni and Cheese and Broccoli Florets Dinner because it might contain undeclared egg whites. People who have an allergy or severe sensitivity to egg whites run the risk of serious or life-threatening allergic reaction if they consume this product. However, the product is safe for persons who are not allergic to egg whites. The product was distributed nationwide through retail stores.

The product was packed in a 12-ounce paperboard carton marked with the following production codes: 14 E1206, 14 F1206, 14 G1206, and 14 H1206. The production code is located on the side panel in the consumer information box.

The recall was initiated after it was discovered that the product containing egg whites was distributed in packaging that did not reveal the presence of egg whites. Subsequent investigation revealed that the problem was caused by the company using a macaroni product for these production codes that did not match the product's ingredient statement. Production of the product resumed utilizing a macaroni product that does not contain egg whites.

Coleslaw Contaminated with Salmonella Recalled

The FDA's San Francisco District Office was notified on February 2, 2001, that the New York State Department of Agriculture and Market found Salmonella typhimurium in a sample of ready-to eat Dole classic cole slaw, 1-pound (16-pound) size packages. The FDA's San Francisco District Office notified the corporate headquarters of Dole Fresh Vegetables, Inc., in Salinas, California. Dole initiated a recall of its Dole brand classic cole slaw, in 16-pound (1-pound) packages.

The products were manufactured in Yuma, Arizona, on January 17, 2001, and distributed nationwide. The code under recall was "Best if Used by 02 05 01". On February 2, 2001, Dole sent out a press release concerning the recall of the classic cole slaw, 16-ounce retail size. Dole's corporate headquarters in Salinas transferred the management of the recall to it's office in Westlake Village, California (The FDA's Los Angeles District Office's area). The FDA's Los Angeles District Office's Recall Coordinator monitored the recall.

Seizure at Contes Pasta

On April 24, 2001, FDA investigators accompanied the U.S. Marshals Service in a seizure at Conte's Pasta located at Vineland, New Jersey. The firm manufactures a variety of products including Shrimp Ravioli, Crabmeat Ravioli, Seafood Manicotti, Shrimp Pasta, and other products. The various products were worth approximately $5,246.00.

The products were relabeled and brought into compliance on December 18, 2001, at which time they were released by the U.S. Marshal. The Consent Decree of Condemnation was entered on August 20, 2001. Previously, FDA conducted an inspection of the firm on November 17, 19 and 22, 1999. During the inspection FDA investigators observed serious violations of the Fish and Fishery Product regulations whereby the products may have been rendered injurious to health. On December 9, 1999, the FDA's New Jersey District Office issued a three-page Warning Letter to the firm detailing the inspectional observations.

Seafood

Recall of Smoked Fish Contaminated with Listeria

The FDA's Philadelphia District Office reported that Homarus/Marshall Smoked Fish, Inc. (a.k.a. Premier Smoked Fish Inc.) Bensalem, PA, issued a press release on February 1, 2001, for Marshall's Best Smoked Nova Spread due to the presence of Listeria monocytogenes. FDA investigators from the New Jersey and Philadelphia Districts found the contamination in a sample collected during a recent Seafood HACCP inspection of the firm. The batch number involved in the recall is 12146. The use by codes are 3/16/01 for the 5 pound container and 4/16/01 for the 8 ounce container. The product was sold at retail stores in New York.

FDA Inspection Results in Recall of Seafood Products

The FDA's New England District initiated an inspection of Silver Spoon Salads Co., Inc., Chelsea, Massachusetts. The inspection on February 28, 2001, resulted in a firm initiated recall. During the inspection the firm was observed to be producing Seafood Salad, a product that contains imitation crabmeat as a raw product. The raw product label was reviewed and compared to the finished product label. Investigators noted that the finished product label did not contain all ingredients listed in the raw product, including wheat flour, wheat starch, and egg whites.

The firm also produces Seafood Salad sandwiches using the same raw materials, and again the finished product label was observed to be inaccurate. Another product manufactured by the firm and observed to contain the same raw ingredient was Seafood Stuffing. The label for this item was reviewed and also found to be lacking the declaration of the surimi ingredients, as well as others. The firm initiated a recall of all seafood products containing this raw ingredient. FDA considers eggs to be a Class I allergen, and wheat products a Class II allergen.

Warning Letters Issued for HACCP Deficiencies

  • The FDA's Seattle District Office issued a Warning Letter on February 15, 2001, to Felix Custom Smoking, Monroe, Washington. FDA conducted an inspection of the firm on October 5 - 13, 2000, which disclosed serious deviations from the Seafood HACCP regulations. The firm failed to list in their HACCP plan, and control for, the food safety hazard of scombrotoxin formation in tuna jerky. In addition, the firm failed to list the critical control point of cooling for hot smoked vacuum packaged tuna; failed to implement the record keeping system listed in the HACCP plan; failed to list critical limits in the HACCP plan that are: utilized in the production process; failed to list complete monitoring procedures for all critical control points; and, failed to address the cause of the deviations for pre-determined corrective actions.
  • The FDA's Detroit District Office issued a Warning Letter on July 18, 2001, to the Vice-President of United Fish Distributors, Inc., Detroit, Michigan, for HACCP deviations. FDA conducted an inspection of the facility on November 21 - 29, 2000. During the inspection, the FDA investigator observed deviations from the principles of HACCP and the significant requirements of the program. These deviations included inadequate critical control point to control the histamine of scombrotoxin species and lack of monitoring and recording the times and temperatures as listed in the HACCP plans for scombrotoxin species, smoked fish, and molluscan shellfish. The firm also had inadequate corrective actions for scombrotoxin and molluscan shellfish HACCP plans.
  • On July 11, 2001, the FDA's New Jersey District Office issued a Warning Letter to Fisherman's Dock Cooperative, Inc., Point Pleasant, New Jersey. FDA inspected the firm on April 30- and May 2, 2001. The firm processes high-risk seafood products such as Bluefish, Mackerel, and Shad. A previous inspection and untitled letter failed to garner corrections from the firm, therefore, the district issued a Warning Letter based on the most recent inspection. The letter cited issues such as failure to have adequate critical limits for control points, failure to list temperature as a critical limit during processing of histamine producing fish, and failure to record monitoring observations regarding the control of histamine formation.
  • The FDA's Florida District Office issued a Warning Letter on July 3, 2001, to Frenchy's Seafood Company, Clearwater, Florida. An FDA inspection on May 23, 2001, revealed that the firm had no HACCP plan for scombrotoxin forming fish products and an inadequate record keeping system for their HACCP plan for smoked fish. The firm was not recording the actual monitoring observations for cook temperature and time and internal temperature and time at the smoking critical control point, or the cooling down temperature and time at the cooling after smoking critical control point, to control the food safety hazard of C, botulinum toxin formation.
  • On May 11, 2001, the FDA's Baltimore District Office issued a Warning Letter to Virginia Seafood, Ashland, Virginia, for seafood HACCP violations. An FDA inspection of the firm on May 1, 2001, revealed deviations from the "Critical Limits" in the firm's HACCP plan for smoked fish, with no corrective actions taken; incomplete information recorded on batch records; and a lack of sanitation monitoring records. The firm had received an untitled letter on June 27, 2000, for similar violations.
  • The FDA's Atlanta District Office issued a Warning letter to Imaex Trading Company, Inc., Norcross, GA, on March 20, 2001. The investigation on October 18-19, 2000, documented deviations from FDA's seafood HACCP importing regulations. The firm failed to have product specifications that are designed to ensure that the fish and fishery products they import are not injurious to health.
  • The FDA's Chicago District Office issued a Warning Letter to Noon Hour Products, a secondary processor of pickled herring, located in Chicago, Illinois. The letter followed a inspection on November 15, 16, and 28, 2000, at the firm. FDA investigator documented both domestic and import seafood HACCP deviations. The most significant deviation in the firm's operation involved a failure to record the internal temperature of herring to evaluate for histamines. The firm was previously issued an untitled letter dated May 27, 1998, for the same deficiency.
  • The FDA's New Orleans District Office issued a Warning Letter to Dauphin Island Parkway Seafood, Inc., Mobile, Alabama, on May 14, 2001. An FDA inspection of the firm on April 18 - 20, 2001, disclosed continuing HACCP violations in the production of ready-to-eat cooked crawfish. The firm had no HACCP plan for its crawfish product. Other deficiencies observed during the inspection included inadequate cooking time and temperature, no sanitation monitoring records, and gross insanitary conditions, such as rodent excreta, live cockroaches, flies, and ants, found in the processing room.
  • The FDA's Denver District Office issued a Warning Letter to Great Plains Foods, Brighton, Colorado, for Seafood HACCP deficiencies for the firm's alligator jerky and canned alligator meat. An inspection of the firm on March 13 - 14, 2001, and again on May 9 - 10, disclosed that the firm was using a generic USDA HACCP Plan for their jerky. In addition, the firm did not have an HACCP plan for the alligator meat hermetically processed in 7 ounce cans. In addition the HACCP fails to include critical limits to monitor procedures for the hazard of Staphylococcus aureus growth and toxin formation.

Ghio Seafood Products Recalls Hot Smoked Salmon Because of Possible Health Risk

Listeria In Hot Smoked Salmon Results In Recall

On September 6, 2001, Ghio Seafood Products of San Diego, California, issued a Press Release announcing that the firm was recalling hot smoked salmon distributed by Pacific Shellfish in San Diego during July and August 2001. The product was being recalled because it had the potential to be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in small children, frail or elderly people and others with weakened immune systems.

The product was distributed under Pacific Shellfish label and was marked with one of the following three production dates: 7/19/01, 8/9/01, or 8/22/01. The product was packaged was packaged in 6 pound vac-pak portions. The recall was a result of routine sampling, which revealed the finished product contained the bacteria in one sample.

Smoked Salmon Detained

FDA Laboratory Sampling Finds Listeria in Norwegian Smoked Salmon

On March 29, 2001, the FDA's Florida District Office collected a sample of Norwegian Smoked Salmon distributed by Scanfood AS, Kvasnes, Eidsnes, Norway. On April 13, 2001, the SRL found the sample to be violative for Listeria monocytogenes Type 1. The entry consisted of 48 master shipping cases with the total weight of 603 lbs. and the invoiced value of $9,035. The entry was been detained and the manufacturer was recommended to be placed on DWPE under Import Alert 16-39.
Voluntary Destruction

Unrefrigerated Smoked Tuna Destroyed

On June 12, 2001, the FDA's Philadelphia District Office the district witnessed the voluntary destruction of 1,000 pounds of vacuum packaged smoked tuna imported from Mexico by Fresh Made Company of Philadelphia. The $4,400.00 shipment was detained by the FDA's Philadelphia District Office and destroyed by the importer after New York Regional Laboratory found water phase salt levels ranging from 0.8 to 1.8%. In addition, the FDA's Philadelphia District Office documented that the product had been stored without refrigeration for a period of time.

Decomposed Tuna Destroyed

The FDA's San Francisco District Office reported a Las Vegas Consumer Safety Officer witnessed the voluntary destruction of 33 cartons (330-pounds), of frozen vacuum packed tuna steaks by J & J Seafood Co. This surveillance sample was collected from the firm by a FDA's San Francisco District Office Consumer Safety Officer and an Analyst on a recent HACCP inspection. The product was from Singapore and purchased from Seabreeze Seafood International, S. El Monte, California. The FDA's Seattle District Office found 11 of 18 sub-samples of the tuna decomposed.

Listeria Found in Salmon Salad and Smoked Sablefish

FDA Inspection Discloses Listeria Monocytogenes Type 4 in Salmon and Sablefish

The FDA's Philadelphia District Office conducted an inspection at Homarus/Marshall Smoked Fish, Inc. (d.b.a. Premier Smoked Fish Inc), Bensalem, Pennsylvania, on June 19 - 27, 2001. Investigators collected samples of finished products which were forwarded to the FDA's New York-Regional Laboratory for analysis. Two of the samples (Kippered Salmon Salad and Cold-Smoked Vacuum-Packed Sablefish) were found positive for Listeria monocytogenes type 4. The firm was notified of the results and their corporate office (Sea Specialties, Inc., Miami, Florida, decided to recall the two products.

Recall of Swollen Cans of Tuna

On June 26, 3001, Felpausch's Food Centers, Hastings, Michigan, issued a press release alerting the public of a recall involving swollen 6 ounce cans of Felpausch brand light chunk tuna in spring water. According to the firm's press release, the problem was revealed while a state inspector was making some purchases in a local Felpauch store. FDA conducted a joint inspection with the Michigan Department of Health (MDA) at Felpausch Foods' distribution center in Battle Creek, Michigan. Three lots of abnormal cans were observed and sampled by both MDA and FDA. MDA inspectors seized the lots of the tuna totaling 47,520 - 6 ounce cans. The tuna was imported from Papua, New Guinea. The district monitored the recall.

Firm Voluntarily Destroys Lot Under FDA Supervision

The FDA's Los Angeles District received approval on July 26, 2001, for a seizure of raw slipper lobster tails, imported by Tai Foong of Sattle, Washington, and stored at Prefered Freezer in Los Angeles, California. The same day the seizure papers were prepared for delivery to the U.S. Attorney, the firm agreed to voluntarily destroy the product under FDA supervision.

Seizure at Ruggieros Seafood, Inc.

Raw Clams Labeled as Cooked Are Seized

On May 24, 2001, the FDA's New Jersey District Office investigators and the New Jersey State Department of Health accompanied the Deputy U.S. Marshall to Ruggiero's Seafood Inc., Newark, New Jersey, to carry out a seizure of adulterated and misbranded frozen whole clams. The clams had been imported from China and New York Regional Laboratory and New Jersey State analyses had determined that they were raw, not cooked as labeled. Approximately 47,690 pounds of product labeled as Fisherman's Pride pre-cooked and fresh frozen clams were seized having an approximate value of $72,000.

Consent Decree of Permanent Injunction Against Jensens Old Fashioned Smokehouse

Court Enjoins Smoked Seafood Fim for Serious Violations of HACCP Regulations

In January 2001, the owner of Jensens Old Fashioned Smokehouse, Inc., Seattle, Washington, signed a Consent Decree of Permanent Injunction in the Western District of Washington. This is the second injunction case for the FDA's Seattle District Office to be brought against a company and its owner for violating the Seafood HACCP Regulations, 21 C.F.R. 123. The firm has a history of violative inspections of their smoked seafood operation since 1998.

The most recent inspection in July 2000, documented serious deficiencies with the firm's HACCP plan and operational procedures, along with problems with their sanitation program. Samples of hot smoked salmon were collected and found below 3.5% water phase salt. FDA also found Listeria monocytogenes (L. mono) in 3 of 4 finished product samples of the firm's vacuum-packaged hot smoked salmon. Bacterial sampling found 8 of 43 environmental swabs and brine collected during the inspection to be positive with Listeria monocytogenes.

Sigma International Enters Plea Agreement

Firm Enters Plea Agreement For Conspiracy to Sell Decomposed Shrimp

Previously in 1996, Sigma International Inc., St. Petersburg, Florida, and two of its executives, were convicted of fraud and conspiracy for selling decomposed shrimp, which the company washed in a concoction of bleach, lemon juice and copper sulfate to disguise the odor and interfere with the analysis of the shrimp. The company was fined $1.4 million and the vice president and plant manager were sentenced to 41 months and 27 months prison terms in addition to individual fines. Sigma appealed the sentences and conviction to the 11th Circuit Court.

In March 2001, the appellate court reversed the District court and dismissed the indictment, which led to their conviction, on the grounds of prosecutorial misconduct. During the 3rd week of May 2001, Sigma entered into an agreement with Federal prosecutors in which the company agreed to plead guilty to all 12 charges for which it was convicted and to not seek restitution of the fine, in exchange for the government dropping all charges against the two company executives.

Seafood International, Inc. Found in Civil Contempt

Court Orders Firm to Pay $40,000 in Disgorgement to U.S. Treasury

United States v. Seafood International, Inc. ( W.D. La.) On October 24, 2000, U.S. District Court Judge Richard Haik granted the government's Motion for an Order to Show Cause why Defendants should not be held in civil contempt for violation of the Consent Decree of Permanent Injunction. The government sought to hold the defendants, a seafood processing plant and its president and manager, in contempt for continuing to process seafood that was contaminated with filth (E. coli) and manufactured under insanitary conditions. The defendants also violated the consent decree by continuing to introduce seafood into interstate commerce after receiving a letter from FDA requiring a cessation of operations.

On May 8, 2001, U.S. District Court Judge Richard Haik denied defendants' Motion for New Trial, Motion to Stay Execution of Judgment Pending Hearing, and Motion for Relief of Judgment. The corporate defendant, Seafood International Inc., is a crabmeat and seafood processor located in Louisiana. Defendants' motions challenged the Court's recent Order of Civil Contempt which ordered, among other things, that defendants: pay approximately $40,000 in disgorgement to the U.S. Treasury, pay $8,000 to the government for costs related to the contempt proceedings, pay a fine of $1,000 per day for any future violations, escrow $10,000 to ensure payment of any future violations, and not make any intra- or interstate commerce shipments of seafood products when FDA orders a cessation of operations. Defendants' alleged that the award of disgorgement of proceeds should be limited only to profits not proceeds, that the individual defendant should not be held in contempt, that the court lacked the authority to order relief in the form of fines for future non-compliance, and that they are not financially able to pay the penalties ordered. In denying defendants' motions, the court noted that it would approve a manageable payment schedule for defendants' if the parties jointly submit one to the court.