Last Update: August 07, 2003
Warning Letter Issued to Sprout Growing Facility
FDA Warns Firm of Food Bourne Illness Associated with Sprouts
The FDA's Los Angeles District Office issued a Warning letter on March 20, 2001, to Kowalke Family Sprouts, Canoga Park, California. An FDA inspection of the facility on July 17 and 19, 2000, revealed that the sprouts had been prepared, packed or held under insanitary conditions. The Warning Letter cited the firm for failure to test sprouts and/or spent irrigation water for each lot as per the FDA guidance document Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production. The inspection revealed that firm had done no testing, and had other serious CGMP deficiencies, including, using non-sterile soil, vermin in the facility, and numerous potential cross-contamination issues.
The Warning Letter clarified the Agency's position on the definition of sprout to cover products identified as salad greens by the firm, including Daikon radish, safflower, pea sprouts, and wheat grass. The Warning Letter also noted that the FDA considers ready-to-eat sprouts a food commodity that is unique from other raw agricultural products due to the food-borne illness outbreaks that have been associated with these products.
Warning Letter Issued For Insanitary Conditions
On June 20, 2001, the FDA's Florida District Office issued a Warning Letter to Chung Farming, Orlando, Florida, for failure to adopt effective preventive controls to reduce the risk of raw sprouts. An FDA inspection of the facility on May 30, 2001, was conducted at the facility as part of an investigation of an outbreak of Salmonellosis in Orlando attributed to sprouts. FDA analyses of samples collected at Chung Farming were negative for Salmonella; however, the inspection found the sprouts being produced under insanitary conditions. The firm had not conducted any microbial testing of spent irrigation water and no sampling method or plan had been established. Containers used for storing finished sprouts had holes in the bottom and were in direct contact with insanitary surfaces, and finished sprouts stored in a walk-in cooler were covered with a dirty blanket.
Illegal Pesticides Found In Produce
- The FDA's Florida District Office collected a sample of imported fresh squash from Delicias Naturales N.T. S.A., Cartago, Costa Rica, on February 21, 2001. The lot consisted of 97 cartons. (221 Kg) valued at $690. Southeast Regional Laboratory analysis revealed the sample positive for methamidophos and acephate. The shipment was detained.
- On July 20, 2001, the FDA's Florida District Office visited Hellmann Worldwide Logistics, Inc., Orlando, Florida, and witnessed the destruction of 2,225 pounds of fresh tomatoes imported from Holland. The tomatoes were adulterated with the pesticide procymidone and the value of the lot was $1,680.
- Two shipments of IQF pea pods from China were detained for the presence of Methamidophos, a pesticide for which there is no tolerance on this product. Grower/shippers are Zhejiang Haitong Food Import & Export Company of Zhejiang, China and Quick Freeze Food Products of Taicang City, China. A recommendation to place all processed fruits and vegetables of Chinese origin on countrywide alert was sent to DIOP for review. A review of Import Alert 99-08 showed that currently 56 percent of the products on the alert from China have violative residues of Methamidophos.
- The FDA's Florida District Office collected a sample of fresh snow peas on 3/29/01, distributed by Agro Exportadora San Lucas, Sacatepesquez, Guatemala. On 4/10/01, the SRL found the sample to be violative for the pesticide, methamidophos. The entry consisted of 2,000/10 pound cases (20,000 lbs.) with the invoiced value of $6,000.00. The entry has been detained, and the grower/shipper will be recommended to be placed on DWPE under Import Alert 99-14.
FDA Assists Customs In Seizure of Chipotle Peppers
On May 10, 2001, FDA investigators from the FDA's Laredo Resident Post accompanied U.S. Customs officials from the Office of Investigations, and Fines Penalties and Forfeitures to assist in the seizure of 90 cases of La Morena brand name canned chipotle peppers. FDA investigators from the Southwest Imports Division initiated the investigation and found the refused lot to be substituted. This was a collaborative effort between FDA's Laredo Resident Post, Southwest Imports Division Compliance Branch, and U.S. Customs Service.
Vessel Watering Points
Warning Letter Issued for Watering Point
On September 6, 2001, the FDA's San Francisco District Office issued a Warning Letter to Classic Charter, Inc., Visalia, California. The facility provides watering point and bus waste service for Classic Charter buses. The FDAs San Francisco District Office inspection on August 7, 2001, found numerous deficiencies, the most notable of which was that there was no back-flow prevention device attached to the potable water line that was connected to a hose in the bus lavatory service area. In addition, there was no soap available at the employee hand-washing sink, and the potable water outlets for the busses were uncapped. The facility has been placed on provisional status.
Ice Cream Manufacturer Pleads Guilty to Fraud and Misbranding Charges
Corporation and Two Officials Plead Guilty to Conspiracy to Commit Fraud and Misbranding
On February 20, 2001, Jocel Manufacturing Corporation and 2 of its corporate officials, Jorge Cintron Fernandez and Jorge Cintron Renta, entered a guilty plea in the U.S. District Court in Puerto Rico. The defendants each plead guilty to 1-count of conspiracy to commit fraud and 1-count of misbranding food represented to be ice cream, which did not meet the definition and standard of identity. The original 10-count indictment was handed down in April 2000, after a Grand Jury evaluated evidence from multiple inspections, sample analysis, interviews, and the execution of a search and seizure warrant.
The plea agreement was reached after the District Court dismissed a motion filed by the defendants challenging the admissibility of the evidence supporting the charges. The penalty for the offenses charged carry a maximum sentence of 5 years (Count One) and 3 years (Count 6) of imprisonment and a term of up to three years of supervised release for each count. In addition, the offenses charged carry a maximum fine of $250,000.00 per individual and $500,000.00 for the corporation for each count, and/or an order of restitution. The Department of Justice, Office of Consumer Litigation represented the government in this case and continues to work closely with the FDA's San Juan District Office.