Last Update: August 07, 2003
Warning Letters Issued for CGMP Violations
- On March 8, 2001, the FDA's New Orleans District Office issued a Warning Letter to Prestage Farms, Inc., West Point, Mississippi. The firm manufactures medicated and non-medicated feeds for its own integrated swine enterprise. An FDA inspection of the facility on February 21 - 22, 2001, disclosed significant deviations from the Current Good Manufacturing Practice (CGMP) requirements for Medicated Feeds. These deviations included: failure to perform assays for the active drug ingredient in one product since 1999; failure to perform appropriate investigations and/or corrective actions for out of limit assays; and failure to have master production records.
- The FDA's Dallas District Office issued a Warning Letter to Purina Mills, St. Louis, Missouri, on March 23, 2001. The Warning Letter followed the an FDA inspection of Purina Mills, Oklahoma City, Oklahoma, on February 2-6, and 13-14, 2001. The firm failed to follow Purina's SOP for Drug Sequencing Requirements. The SOP provides for sequencing production (without flushing the mixer) of animal feeds for a species for which a drug component of a prior medicated feed is not approved. Additionally, the firm had distributed bagged medicated feeds since June 2000, with faulty tagging equipment and no control to ensure that all bagged feeds were completely labeled.
Bovine Spongiform Encephalopathy (BSE)
To help prevent the establishment and amplification of BSE in the Unites States, FDA implemented a final rule that prohibits the use of most mammaliam protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997.
On August 23, 2001, Department of Health and Human Services (DHHS) Secretary Tommy Thompson unveiled a department-wide action plan outlining new steps to improve scientific understanding of BSE, commonly known as "mad cow disease," and related diseases known as TSEs. The plan incorporates a comprehensive approach to further strengthen surveillance, increase research resources, and expand existing inspection efforts to prevent BSE and TSEs from entering or taking hold in the U.S.
Warning Letters for BSE Violations
FDA Inspection Finds Numerous Violations of BSE Regulations
On August 8, 2001, the FDA's Seattle District Office issued a Warning Letter to the owner of an animal feed manufacturing facility located in Tualatin, Oregon. FDA investigators conducted an inspection on July 12, 2001, which disclosed violations of the bovine feed ingredient regulations. The inspection revealed that the firm failed to separate the receipt, processing, and storage of products containing prohibited material from non-prohibited material; failed to establish a written system, including clean-out and flushing procedures, to avoid commingling and cross-contamination of equipment; and failed to maintain records sufficient to track the materials. In addition, the firm failed to label products with the required cautionary statement, Do Not Feed to Cattle or Other Ruminants.
Gamecock Feedmill Found Violating BSE Regulations
On July 12, 2001, the FDA's Cincinnati District Office issued a Warning Letter to the Carrollton Farmers Exchange, Carrollton, Ohio, a feed mill. FDA investigators conducted an inspection on June 25, 2001, which found the firm was manufacturing gamecock feed containing prohibited proteins. The firm was not labeling the gamecock feed with the cautionary statement, Do not Feed to Cattle or Other Ruminants; was not flushing or sequencing after manufacturing the feed, and was not maintaining distribution information.
Warning Issued for Lack of Required BSE Cautionary Statement
The FDA's New Orleans District Office issued a Warning Letter to Shields Feed and Supply, Coffeeville, Alabama, on March 7, 2001. An inspection conducted on February 1, 2001, of Shields animal feed operation showed the finished product label lacked the required ruminant cautionary statement. In addition, mixing and distribution records were not maintained; no written procedures were established for mixer cleaning; and the corn used for the mixer cleaning was not labeled and quarantined.
Firm Warned for No Measures to Avoid Commingling of Feed
On May 3, 2001, the FDA's Minneapolis District Office issued a Warning Letter to Adrian Elevator, Inc., a Butterfield, Minnesota, a manufacturer of animal feeds. On March 16, 2001, an inspection conducted by the State of Minnesota (on behalf of FDA) found significant deviations from the BSE regulations. The firm failed to provide adequate measures to avoid commingling or cross-contamination and failed to maintain adequate records to assure that prohibited animal proteins were not incorporated into feeds that may be used for ruminants. For example, there was no documentation to verify that the amount of "flush" being used was sufficient, and there were no procedures or documentation to verify that production was properly sequenced and that flushes were performed.
Warned Issued for Failure to Take Adequate Steps to Prevent BSE
The FDA's Seattle District Office issued a Warning Letter on May 14, 2001, to Wallowa County Grain Growers, Inc., Enterprise, Oregon, for violations FDA regulations regarding Animal Proteins Prohibited in Ruminant Feed. An inspection of the firm on April 11 - 12, 2001, disclosed that the firm was not taking adequate steps to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE) in that they failed to separate the receipt, processing, and storage of the product containing prohibited materials from non-prohibited material; failed to establish a written system, including clean-out, and flushing procedures to avoid commingling and cross-contamination of common equipment; and failed to maintain records sufficient to track the materials throughout the receipt, processing, and distribution of product.
Contract Feed Manufacturer Found Violating BSE Regulations
On May 1, 2001, the FDA's Chicago District Office issued a Warning Letter to Material Resources, a contract feed manufacturer in Washington Park, Illinois. An inspection of the firm in March 2001, disclosed several deviations from the BSE regulation. These included failure to maintain written procedures and provide adequate means to prevent commingling between feeds containing prohibited protein and all other protein products. The firm also lacked adequate records to track products that contained prohibited protein throughout their receipt and processing.
Firm Warned for Lack of Written Procedures for Clean-Out to Prevent Commingling
On June 6, 2001, the FDA's Seattle District issued a Warning Letter to Superior Feeds, Chester, Montana. The firm is an animal feed manufacturing operation. An inspection of this firm on April 25, 2001, revealed that the firm failed to label their product with the required statement, Do Not Feed to Cattle or other Ruminants. In addition, the facility failed to maintain written procedures specifying the clean-out or sequencing procedures used to prevent commingling or cross-contamination of ruminant and non-ruminant containing feeds.
FDA Inspection Discloses Hog Feed Lacks BSE Statement
The FDA's Minneapolis District Office issued a Warning Letter on May 30, 2001, to Round Lake Farmers Coop, Round Lake, Minnesota. The firm manufacturers animal feeds. An inspection by the State of Minnesota (on behalf of FDA) on March 30, 2001, found significant deviations from the requirements for Animal Proteins Prohibited in Animal Feed. The firm failed to label a hog feed with the required BSE caution statement. In addition, they failed to establish and implement procedures for handling prohibited animal proteins and failed to maintain records sufficient to track the receipt of products containing prohibited animal proteins.
Possible Contamination of Fish Food Leads to Detention
The week of March 7, 2001, the FDA's New York District Upstate Import Operations Branch detained three entries of fish food under Import Alert 99-25 (Detention Without Physical Examination of Animal Feed, Animal Feed Ingredients And Other Products For Animal Use Consisting Or Containing Ingredients of Animal Origin) due to possible contamination with the infectious agent for BSE. The country of origin for the fish food was the Federal Republic of Germany. The local USDA/Philadelphia/PPQ Office was notified.
Vitamin Supplement for Pets Detained
The week of February 14, 2001, the FDA's Atlanta District reported the detention of 8,777 cartons of vitamin supplements for cats, kittens, puppies, and older dogs. The detention included both dog and cat treats. The detention was based on Import Alert 99-25 (BSE). The products were manufactured by Beaphar, Raalte, Netherlands, and were valued at approximately $63,000.
Calf Ration Detained
The FDA's New York District Office reported that during the week of March 21, 2001, FDA investigators detained an entry of Calf Starter Ration and Calf Finisher Ration under Import Alert 99-25, since some of the ingredients originated from France and The Netherlands (both of which are listed on IA 99-25 as BSE susceptible countries). The manufacturer of the feed was Grober Inc., Cambridge, Ontario, Canada, and the consignee was Majestic View Farms in Milan, Pennsylvania. The USDA/APHIS/PPQ Buffalo, New York office was contacted.
Recall of Various Animal Feed Products
- The FDA's Cincinnati District Office reported that The Hyland Company, Coalton, Kentucky, conducted a recall of various animal feed products, including Ultra Bloom and Endurance Plus horse feeds, due to cross-contamination with prohibited bovine material. The firm's corrective action involved the application of a sticker-label that contained the required BSE warning statement on the labels of their affected products. The firm initiated the recall by telephone on July 25, 201, and letters on July 31, 2001.
- During an FDA inspection by the Cincinnati District Office investigators determined that Central Farm Supply of Kentucky, Inc., Louisville, Kentucky, had received poultry feed manufactured by Burkmann Mills, Bowling Green, Kentucky, that contained prohibited protein, but lacked the required caution statement. On May 3, 2001, the district and the University of Kentucky Regulatory Services Division met with the responsible parties of the mill's parent firm, Burkmann Mills London, London, Kentucky. During the meeting the firm volunteered to recall all feed products manufactured at the Bowling Green mill due to the lack of the required caution statement.
FDA Announces Animal Feed Recall
On January 30, 2001, FDA issued a Press Release announcing the results of tests taken on feed used at a Texas feedlot that was suspected of containing meat and bone meal from other domestic cattle -- a violation of FDA's 1997 prohibition on using ruminant material in feed for other ruminants. The results indicated that a very low level of prohibited material was found in the feed fed to cattle.
FDA determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds. It is important to note that the prohibited material was domestic in origin (therefore not likely to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very low level, and fed only once. The potential risk of BSE to such cattle was therefore exceedingly low, even if the feed were contaminated.
According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The challenge to regulators and industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant animal materials in feed for other ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of protections, to keep American cattle free of BSE."
Despite this negligible risk, Purina Mills, Inc., nonetheless announced that it was voluntarily purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed containing the prohibited material. Therefore, meat from those animals would not enter the human food supply. FDA believes any cattle that did not consume feed containing the prohibited material was unaffected by this incident, and should be handled in the beef supply clearance process as usual.
FDA believes that Purina Mills acted responsibly by first reporting the human error that resulted in the misformulation of the animal feed supplement and then by working closely with State and Federal authorities. This episode indicates that the multi-layered safeguard system put into place is essential for protecting the food supply and that continued vigilance needs to be taken, by all concerned, to ensure these rules are followed routinely. FDA continues to work with USDA as well as State and local officials to ensure that companies and individuals comply with all laws and regulations designed to protect the U.S. food supply.
Warning Letters Issued for Illegal Drug Residues
The FDA's New England District Office issued a Warning Letter on February 1, 2001, to D & K Farm, Middlefield, Connecticut, for selling a dairy cow for slaughter as human food which had the presence of Gentamicin. Gentamicin is not approved for use in cattle. An FDA inspection of this dairy operation located in Wallingford, Connecticut, disclosed that in November 2000, the owner sold a dairy cow for slaughter as human to a livestock dealer. USDA analysis of tissue samples collected from that animal identified the presence of Gentamicin in the animalÂ’s kidney at a level of 4.74 ppm. The Warning Letter also noted that the owner holds animals under conditions which are so inadequate that diseased animals and/or medicated animals bearing potentially harmful drug residues are likely to enter the food supply.
- On January 31, 2001, the FDA's New York District Office issued a Warning Letter to Jay N. Martin, a producer and the owner of Jay N. Martin, a.k.a. Horizon Dairy, in Clyde, New York. An FDA inspection of the firm on November 20-22, and 27, 2000, confirmed that the firm offered two dairy cows for slaughter with drug residues. A USDA sample analyses indicated the presence of penicillin at illegal levels in the kidneys of both slaughtered cows, and streptomycin, for which there is no published tolerance.
- The FDA's Minneapolis District Office issued a Warning Letter on August 28, 2001, to Paskewitz Cattle Company of Vesta,Minnesota. The Warning Letter cited adulteration of two animals (a dairy cow and a steer) with residues of penicillin that were above tolerance.The investigation conducted by the Minnesota Department of Agriculture found that Paskewitz Cattle did not keep adequate records of their own drug treatment, and they did not have an adequate system for handling purchased animals that may have been treated with drugs.
- The FDA's Denver District Office issued a Warning Letter to DeJong Dairy, Greeley, Colorado, on February 23, 2001, citing adulteration charges due to the presence of penicillin residue in a cow offered for slaughter.An FDA inspection of this dairy farm on February 7 and 9, 2001, confirmed that the owner offered an animal for slaughter in violation of the FD&C Act. Specifically, on October 27, 2000, Mr. DeJong offered a cow for slaughter as human food. USDA analysis of tissue samples collected from this cow identified the presence of penicillin residues at 0.89 ppm in the kidney.A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissue of cows. The analysis also identified the presence of gentamicin residue at 13.31 ppm in the kidney. The Warning Letter also addressed poor animal husbandry practices which lead to the residue. USDA condemned this cow which was also diagnosed with septicemia, pneumonia, pleuritis, peritonitis, hepatitis, nephritis, and lymphedenitis.
- The FDA's San Francisco District Office issued a Warning Letter to Parreiro-Pinheiro & Sons Dairy, Tipton, CA. The dairy consigned for sale for human food a cow that had penicillin residue in the liver and kidney that were in excess of the allowable tolerance.The FDA's San Francisco District Office's inspection found that the dairy was not keeping complete medication records and lacked an adequate drug inventory system. In addition, The FDA's San Francisco District Office's investigation found that the dairy was adulterated the drug, in that it was not being used in conformance with its labeled instructions.
On June 15, 2001, the FDA's Denver District Office issued a Warning Letter to North Point Dairy, Clovis, New Mexico, citing adulteration charges due to the presence of sulfadimethoxine residue in a cow offered for slaughter. An FDA inspection of this dairy farm on April 17, 2001, confirmed that a cow was offered for sale for slaughter as food in violation of the FD&C Act. USDA analysis of tissues samples collected from this cow identified the presence of sulfadimethoxine residue of 0.36 ppm in the liver and 0.34 ppm in the muscle. A tolerance of 0.10 ppm has been established for residues of sulfadimethoxine in the edible tissues of beef cows. The Warning Letter also addressed poor animal husbandry practices, which led to the residue.
- The FDA's Florida District Office issued a tissue residue Warning Letter on April 30, 2001, to Larson's Dairy, Inc., Okeechobee, Florida. The FDA conducted an inspection of the diary farm on March 27 and 28, 2001, which confirmed that the firm offered an adulterated animal for sale or slaughter as food. USDA analysis of the dairy calf confirmed the presence of Neomycin in the kidney at the level of 153.12 ppm, more than 21 times the established tolerance of 7.2 ppm. The FDA's Florida District Office's investigation found the calf was fed medicated milk containing Neomycin and Aureomycin.
- On June 22, 2001, the FDA's Baltimore District Office issued a Warning Letter to Richard Edwards, owner of Oakland View Farm, Ridgely, Maryland. Mr. Edwards sold veal calves for slaughter as human food that were treated with Neomycin, a drug that is unapproved for this use. In addition, an FDA inspection on May 30 - 31, 2001, revealed that Mr. Edwards did not maintain treatment records showing the dosage rate, the date the drug was administered, or the time period to withhold treated animals from sale.
The FDA's New Jersey District Office issued a Warning Letter on March 8, 2001, to Frank Carper, Cranbury, New Jersey. An FDA inspection of this facility on October 24 and 27, 2000, confirmed that a horse purchased and sold by Mr. Carper for use as human food was adulterated due to the presence of streptomycin above tolerance levels. USDA analysis of tissues from the equine revealed that streptomycin in the kidney tissue at 0.38 ppm. The tolerance level for streptomycin in the edible tissue of equines is 0.0 ppm. Any animals shipped to USDA slaughter facilities are considered to be for human consumption.
Consent Decree of Permanent Injunction Filed Against Joe Sozinho Dairies
Firm Enjoined for Continuing to Sell Cattle With Violative Drug Residue
On July 30, 2001, a Consent Decree of Permanent Injunction was filed in the Eastern District of California against Joe Sozinho Sr., Danny Sozinho, Dimas Sozinho, individuals d/b/a Joe Sozinho Dairy #1 and Joe Sozinho Dairy #2. The FDA's San Francisco District Office conducted six inspections in response to violative drug residues reported by USDA/FSIS of Joe Sozinho Dairies resulting in two Warning Letters sent to the firm. Despite repeated warnings during the FDA inspections, as well as nine USDA/FSIS warning letters for illegal drug residues, the Sozinho's failed to take adequate corrective action. Voluntary approaches were not successful in correcting the animal husbandry and drug adulteration problems by the Sozinho's.
The Consent Decree permanently restrains and enjoins the Sozinho's from selling cattle for human food until all of the specifications of the Decree are met which include an animal identification system, medication record keeping system, drug inventory system, drug use system, quarantine system, and animal sales certification system. In addition, the Sozinho's reimbursed FDA's costs in the amount of $12,314.38 for investigational expenses incurred subsequent to the 1994 inspection and Warning Letter.
On February 1, 2002, the Sozinho Dairies and the United States filed a stipulation settling a dispute concerning the Dairies' activities while they were under an order of injunction. Under the Stipulation, the Sozinhos admitted to continued violations of the law. They also admitted delivering "at least 56 animals intended for use as food during a thirty-six day period beginning on July 31, and ending on September 4, 2001." The United States had alleged in its motion for contempt that, under the injunction, such deliveries were prohibited until FDA inspected and cleared the Dairies to resume.
The Dairies were not cleared for such sales until December 2001. The Injunction entered by the Court in July 2001 continues in effect. The defendants have paid the U.S. Treasury fines in the amount of $140,000.
Ridge View Farms Consent Decree of Permanent Injunction
Consent Decree Provides FDA With Future Shutdown Authority
United States v. Ridge View Farms, Inc., Carol A. Castine, and Daniel A. Castine (N.D.N.Y.) On August 7, 2001, the U.S. District Court for the Northern District of New York entered a Consent Decree of Permanent Injunction that prohibits the defendants from introducing any food-producing animal into interstate commerce until they have established a system for drug administration and record-keeping to prevent the distribution of any animal containing illegal drug residues in its edible tissues.
The Decree also requires the defendants to provide a copy of the Decree to all persons to whom they have delivered cattle in the past year and to any person to whom they deliver cattle in the future. In addition, the Decree provides the government with the authority to require future shutdown of operations and to impose fines in the event of further violations.
Consent Decree Filed Against H & I Dairy
On November 28, 2000, a Consent Decree of Permanent Injunction was filed in the Eastern District of California against Heduino Brasil (dba H & I Dairy) of Tipton, California. Despite repeated warnings during FDA and the State of California inspections, including six USDA warning letters for illegal drug residue findings in cull cows sold or consigned for slaughter, Mr. Brasil failed to take adequate corrective action. The consent decree permanently restrains and enjoins Mr. Brasil from selling cattle for human food until all the specifications of the decree are met including animal identification, medication record keeping, drug inventory, quarantine, and sales certification systems.
Arie C. Van Leeuwen Sentenced
Violation of Probation Leads to Prison Sentence
United States v. Arie C. Van Leeuwen, (E.D. Cal.) On July 9, 2001, United States District Judge Robert E. Coyle sentenced Arie Van Leeuwen to six months imprisonment and one year of supervised release for probation violations. In 2000, Van Leeuwen pled guilty to two charges of criminal contempt and one felony charge of introducing adulterated food into interstate commerce, resulting from his repeated violations of the statutory and regulatory requirements for administering new animal drugs to food-producing animals.
Van Leeuwen admitted to the following probation violations: failure to obey all laws; failure to submit certain monthly report forms; failure to comply with home confinement conditions; and transporting animals to cattle auctions in violation of the probation terms. In light of Van Leeuwen's history of repeat violations, the Court sentenced him to six months in prison followed by a year of supervised release that includes mandatory attendance in dairy management classes.