Warning Letter Issued to Rendering Operation
On May 7, 2002, FDA's Seattle District Office issued a Warning Letter to Darling International, Inc., Tacoma, Washington. FDA conducted an inspection of the rendering operation on February 22 26, 2002. The inspection revealed a significant deviation from 21 CFR Part 589.2000 Animal Proteins in Ruminant Feed. The inspection disclosed that the firm failed to consistently label the meat and bone meal product with the required cautionary statement: "Do Not Feed to Cattle or Other Ruminants." The meat and bone meal contained beef offal along with other ingredients including chicken, fish, and pork.
Warning Letter Issued for CGMP Violations
FDA Inspection Documents Firm's Failure to Label Product with Cautionary Statement
On December 13, 2001, FDA's New Orleans District Office issued a Warning Letter to CalMaine Foods, Inc., Feed Division, Edwards, Mississippi. An inspection of the medicated feed mill on November 6 9, 2001, disclosed significant deviations from current good manufacturing practice (CGMP) regulations [21 CFR Part 225] during the manufacture of medicated feeds.
FDA's investigation disclosed the following violations: failure to maintain correct documentation of actual drug usage during production; failure to conduct required potency assays on at least three representative samples of each feed at periodic intervals during the calendar year; failure to manufacture medicated feeds in accordance with the master file formula; failure to maintain a daily inventory for each drug used; failure to maintain a drug inventory for each lot of drug on hand; and, failure to maintain complete master record files and production records.
Warning Letter Issued to Feed Manufacturer
FDA's Seattle District Office issued a Warning Letter to All American Feed & Tractor, Sandpoint, Idaho, for deviations from 21 CFR Part 589.2000, Animal Proteins Prohibited in Ruminant Feed. The firm failed to maintain sufficient records to track prohibited animal proteins throughout the receipt, processing, and distribution. In addition, the firm failed to maintain sufficient records and written procedures to prevent cross contamination. The firm also failed to maintain written procedures for cleaning out or flushing equipment after mixing feeds containing prohibited material, or for separating products that might contain prohibited material from ingredients used in ruminant feeds.
Contaminated Animal Feed Supplements Recalled
Animal Feed Supplements
Found to Contain Dioxin
FDA announced the voluntary recall of several animal feed products produced by Quali Tech Inc., a manufacturer based in Chaska, Minnesota. These products are chelated minerals and mineral pre mixes. Chelated minerals are the dosage form most often recommended to assure proper daily intake. Chelation is the pharmaceutical process of bonding each mineral to an amino acid. This bonding makes it easier to digest and assimilate each nutritive mineral for proper utilization in the body. These products are added to feed to provide cattle, pigs, and other livestock with necessary micro nutrients.
This action was taken as a response to a joint investigation conducted by FDA, the Minnesota Department of Agriculture, Minnesota Department of Health, and Minnesota Pollution Control Agency. The operators of Quali Tech cooperated fully with the investigation and recall.
Quali Tech voluntarily recalled these products after laboratory data from several sources indicated that they contained dioxin. In addition, Quali Tech discontinued production of the contaminated products on February 28, 2002.
The only products subject to this recall were the Sea Questra Min and Carbosan products in their original packaging and any premix manufactured by Quali Tech containing these trace minerals. All other mixes containing these trace mineral products were not subject to the recall. For the purpose of this recall a premix is defined as "a uniform mixture of one or more micro ingredients with diluent and/or carrier."
Dioxin is a broad family of chemical compounds that can be produced by a broad range of common human activities. It is released into the environment through burning of various materials including municipal waste, household trash, and fuels like oil, coal, or wood. The manufacture of paper and chemicals, as well as other industrial processes, can also produce dioxin.
Some amount of dioxin is naturally present in the environment and the above activities have caused background levels of dioxin to increase over time. Recently, the efforts of State and Federal environmental agencies have served to reduce these non natural sources of dioxin. As a result, background levels of dioxin have begun to drop.
Addressing the problem of dioxin resulting from the use of the protected minerals and mineral premixes which are the subject of this recall is an important part of the overall effort to reduce dioxin levels in the food chain and environment.
Dioxin compounds are commonly found, at very low levels, in food, particularly in foods containing meat or animal fat. FDA routinely surveys for dioxin as part of its Market Basket survey and through a directed survey of animal products. The low levels of inclusion of the above mineral products in feed and the normal background levels would make it difficult if not impossible to determine whether these products would increase the low level of dioxin in food.
Bovine Spongiform Encephalopathy (BSE)
Ruminant Feed Enforcement Activities
FDA Enforcement Plan Includes Education, Inspections and Compliance Actions for Non-Compliance
To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian 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. To date, active monitoring by the U.S. Department of Agriculture (USDA) has found no cases of bovine spongiform encephalopathy (BSE) in U.S. cattle.
FDA's enforcement plan for the ruminant feed regulation includes education, as well as inspections, with FDA taking compliance actions for intentional or repeated non compliance. The following firms received Warning Letters for violations of FDA's regulation which prohibits the use of most mammalian protein in feeds for ruminant animals:
All American Feed & Tractor April 1, 2002
Dixon Feeds, Inc. October 24, 2001
Finlayson Ag Center November 8, 2001,
Van Dyke Grain Elevators, Inc. April 17, 2002
The Feed Bucket December 11. 2001
Bakery Trading Company July 29, 2002
Darling International, Inc. May 7, 2002
Tyson Foods February 12, 2002
Consent Decree of Permanent Injunction
Firm Enjoined for Introducing Adulterated and Misbranded Medicated Animal Feeds into Interstate Commerce
United States v. Intermountain Farmers Association, Inc., et al., (District of Utah). On September 13, 2002, United States District Judge Ted Stewart signed a Consent Decree of Permanent Injunction against Intermountain Farmers Association, Inc. The Complaint for Injunction alleged that defendants violated the Federal Food, Drug, and Cosmetic Act (Act) by introducing adulterated and misbranded new animal drugs (medicated animal feeds) into interstate commerce. The Complaint also alleged that the defendants violated the Act by causing the adulteration and misbranding of those drugs while they were held for sale after shipment in interstate commerce. The medicated feeds were adulterated because they were not manufactured in accordance with the good manufacturing practice requirements and the drug strength of the feeds differed from that which they were purported to possess.
The feeds also were misbranded because their labeling was false and misleading in regard to drug strength and identity. The Decree contains standard provisions in such cases, for example, up front shutdown, consultant certification of compliance, product recall, payment for inspections and costs, and judicial review. The Decree also requires the defendants to follow a stringent testing schedule for their medicated feeds during the first year after they resume manufacturing.
Warning Letters Issued for Illegal Drug Residues
On July 18, 2002, FDA's Atlanta District Office issued a Warning Letter to John M. Bridges Farm in Shelby, North Carolina. An investigation of the firm's cattle operation on June 6 and 7, 2002, confirmed that the firm offered an animal for sale for slaughter as food. The U.S. Department of Agriculture, (USDA) Food Safety and Inspection Service (FSIS) analysis of tissue collected from that animal disclosed the presence of high levels of penicillin in the kidney and liver tissue. The liver was found to contain 1.08 ppm and the kidney contained .43 ppm of penicillin. The tolerance for residues of penicillin in the edible tissues of cattle is .05 ppm.
- On May 10, 2002, FDA's Seattle District Office issued a Warning Letter to the owner of Vierstra Dairy, Twin Falls, Idaho. An inspection of the firm on March 27, 2002, disclosed violations of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Act. USDA analysis of tissues collected from three culled dairy cows offered for slaughter as human food identified tilmicosin and penicillin residues above established tolerances. The firm was also cited for lacking an adequate system for assuring that animals to which medications are administered are withheld from slaughter for appropriate periods of time to deplete potentially hazardous residues of drugs from edible tissues.
- On or about January 3, 2001, the firm sold a dairy cow for slaughter as human food. USDA analysis of tissue samples collected from that animal identified the presence of tilmicosin in the liver at 25.70 parts per million (ppm). A tolerance of 1.20 ppm has been established for residues of tilmicosin in the liver tissue of cattle (21 C.F.R. Part 556.735). USDA analysis also identified 1.60 ppm in the muscle and 29.90 ppm in the kidney. There is no established tolerance for tilmicosin in these edible tissues.
- On January 18, 2002, FDA's New Orleans District Office issued a Warning Letter to J. Randall Mayes, Pulaski, Tennessee, a dairy farmer. An FDA inspection conducted November 26 28, 2001, confirmed that the farmer sold a cow for use as human food containing gentamicin residues. USDA analysis of tissue samples from the cow sold by Mayes identified the presence of 7.12 ppm of gentamicin in the kidney tissue. There is no established tolerance for gentamicin in cattle. In addition, FDA's investigation found that the dairy farmer held animals under conditions which were so inadequate that diseased animals and/or medicated animals bearing potentially harmful drug residues were likely to enter the food supply.
- In a related action, FDA's New Orleans District Office issued a Warning Letter on January 18, 2002, to Animal Clinic, Pulaski, Tennessee, a veterinary clinic. An FDA inspection conducted on November 27 28, 2001, confirmed that the veterinarian dispensed gentamicin to the abovementioned farmer to treat a cow that was subsequently sold for use as human food containing gentamicin residues. The veterinarian failed to follow the extra label drug use regulations when dispensing a drug not approved for use in cattle.
- FDA's Baltimore District Office issued a Warning Letter to Joseph A. Houck Farm, Culpeper, Virginia, on November 27, 2001. The firm delivered and sold for slaughter a cow whose kidney tissue contained phenylbutazone. The drug had been prescribed for the treatment of another animal in November 2000, and the producer treated the referenced animal without consulting a veterinarian.
Consent Decree of Permanent Injunction in Tissue Residue Case
Illegal Drug Residues Found
in 38 Animals Brought to Slaughter
On December 18, 2001, in the United States District Court for the Northern District of Ohio, Eastern Division, a Consent Decree of Permanent Injunction was signed by Martin D. Yoder, doing business as Martin D. Yoder Livestock. Mr. Yoder was enjoined from introducing adulterated food into interstate commerce because he sold for slaughter cattle that contained unsafe new animal drugs.
During the period from January 1998 to February 2001, Mr. Yoder was responsible for delivering to slaughter 38 animals with excessive levels of new animal drugs in their edible tissues. Some of the drugs found included flunixin, meglumine, tetracycline, penicillin, streptomycin, sulfadimethoxine, and gentamicin sulfate.
Under the consent decree, Mr. Yoder must establish and implement a system that identifies each animal that he purchases for delivery to slaughter with an appropriate tag number. He further must obtain signed written statements from the sellers of the animals as to whether the animal is "medicated." In addition, he must establish and implement a written recordkeeping system documenting any drugs that are administered to the animals, when administered and by whom, the withdrawal period of each drug, and the date the animal is sold or delivered for sale or slaughter. These records must be maintained for at least two years.
Dairy Operation Agrees to Pay $140,000 Settlement
Dairy Operation Admits to Continued Violations of the Law
United States v. Sozinho Dairies, (Eastern District of California). On February 1, 2002, Sozinho Dairies and the United States filed a stipulation settling a dispute concerning the Dairies' activities while they were under an order of injunction. The Sozinho Dairies were enjoined July 30, 2001, for failing to operate in accordance with the Federal Food, Drug and Cosmetic Act's requirements and regulations concerning the administration of drugs to food producing animals.
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, 2001, 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 sales. 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.
FDA Initiates Class I Recall of Pet Treats
Pet Treat Found Contaminated With Salmonella
FDA initiated a Class I recall of Premium Pig Ears, 100 CT, because the product was contaminated with Salmonella. The recalling firm, Pet Magic, Inc., Detroit, Michigan, initiated the recall by telephone on September 21, 2001. The manufacturer of the product was 3 Kuz Foods, Inc., QC, California. The volume of product in commerce was 1,344 cases (100 pieces/case). The product codes were 0235AB, 0236AB, 0239AB, 0242AB, and 0243AB. The product was distributed to Illinois, Michigan, and Ohio.
CGMP Violations Lead to Warning Letter
On March 28, 2002, FDA's Kansas City District issued a Warning Letter to the president of West Agro, Inc., Kansas City, Missouri. FDA conducted an inspection of this drug manufacturing facility on February 12 15, 20, and 25, 2002. This inspection revealed serious deviations from current good manufacturing practice (CGMP) regulations. The inspection revealed the following deviations: no Standard Operating Procedures for the inspection of Out of Specification results; no second person to review laboratory data; no written change control procedures that are necessary to assure the production and process controls will be changed in an appropriate method. In addition to the CGMP violations, the firm refused to allow required access to the complete manufacturing, processing and complaint records, and FDA investigators were not allowed to copy these records.
Nationwide Recall and Seizure of Miracle Leg Paint Veterinary Drug
On May 30, 2002, FDA announced a nationwide recall of Miracle Leg Paint Veterinary Drug because of potential health risk to animals and humans. Equine Miracle Corp. of Grapeland, Texas, recalled its Miracle Leg Paint for horses, 4 ounce container, because the product contained a mercuric chloride blistering agent, a poison to animals and humans. There are no approved veterinary drug products that contain mercury as an active ingredient, and the use of mercuric blistering agents is not generally recognized as safe and effective.
There are safety concerns for humans handling products containing mercuric chloride blistering agents. Poisoning and death have occurred in humans after applying the mercuric chloride products to large areas of the skin. The product, administered topically on horses for the treatment of lameness, shin bucks, bows, chips, splints, and other horse leg ailments, was distributed nationwide to veterinarians, dealers, and consumers.
Seizure of Equine Miracle Paint
Miracle Leg Paint Seized to Assure All Product is Removed From Market
In order to assure that all Miracle Leg Paint subject to the above recall was removed from the market place, FDA's Dallas District accompanied the U.S. Marshals in a seizure of any remaining product, bulk material or in-process products available at the time of the seizure. The seizure was accomplished on October 10, 2002. The complete inventory had been held under Texas Department of Health embargo since FDA's inspection in May 2002. The total value of the goods was approximately $8,000.
Warning Letter to Veterinary Drug Manufacturer
FDA Inspection Discloses Significant CGMP Violations
FDA's Cincinnati District Office issued a Warning Letter on December 6, 2001, to Neogen Corporation, Lansing, Michigan. An FDA inspection of this veterinary drug manufacturing facility, located in Lexington, Kentucky, was conducted on November 16, 2001. The inspection disclosed significant deviations from the regulations for Current Good Manufacturing Practice for Finished Pharmaceuticals.
The deficiencies included the following violations: failure to validate the manufacturing process and controls for the manufacture of Spec-Tuss Palatable Expectorant Powder (active ingredient: guaifenesin) to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess; failure to establish stability data to support the 2 year expiry period for Spec-Tuss' Expectorant Powder; and failure to use a validated test method for release testing. The assay method for guaifenesin in Spec-Tuss' Palatable Expectorant Powder had not been validated for accuracy, sensitivity, specificity and reproducibility; failure to document QA review and approval of production and control records prior to release for distribution of Spec Tuss' Powder lot 0908012; and, failure to maintain omplete information in batch production and control records.
CGMP Deviations Could Lead to Potential Contamination
FDA Inspection Finds Firm Manufactures Waxes and Veterinary Drug Products in Same Blender
On December 12, 2001, FDA's New Jersey District Office issued a Warning Letter to Shamrock Technologies, Newark, New Jersey, a manufacturer of veterinary drug products. An FDA inspection of the firm on October 24, 25, 29, and 31, 2001, revealed significant CGMP deviations. The deviations involved potential contamination of finished products with industrial products.
For example, the firm failed to perform identity testing on raw materials; thus there was no assurance that the veterinary drug products Androhep Plus and Androhep Lite were not contaminated with various industrial products. The firm manufactures waxes, polyterafluoroethylene and polyethylene/poltetrafluoroethylene mixes for the ink and coating industries in the same blender as the above referenced veterinary drug products.
In addition, the firm did not validate cleaning procedures for Androhep Plus and Androhep Me and did not perform any testing on the veterinary drug products for the presence of industrial products. Additionally, the firm had no documentation to support the manufacturing parameters, the order and amount of components, and blending time used to manufacture the finished veterinary drug products.
Labeling of Vet Products Cause Them to be Drugs
On November 27, 2001, FDA's Florida District Office issued a Warning Letter to Custom Manufacturing Corporation, Medley, Florida. An FDA inspection of the facility on May 23 and 30, 2001, disclosed that the firm was a manufacturer of veterinary products. The firm's products were labeled and promoted for conditions or contained ingredients which caused them to be considered drugs. These drugs were adulterated as a result of the firm's deviations from current good manufacturing practice (CGMP) regulations. These deviations included: failure to perform identity tests for raw materials or to verify the validity and accuracy of certificates of analyses received from suppliers. In addition, the firm failed to validate the manufacturing processes; failed to validate the DI/purified water system or the equipment cleaning procedures; failed to establish a stability program; and failed to maintain complete their batch records.
Veterinary Products for Cats, Dogs, and Birds Adulterated
On June 14, 2002, FDA's New York District issued a Warning Letter to the president, Eight In One Pet Products, Inc., Hauppauge, New York. The inspection of this drug manufacturing facility on May 14 and 24, 2002, disclosed multiple deviations from the Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 211). These CGMP violations cause the drug products, including piperazine citrate syrup for dogs and cats, sulfadimethoxine solution for birds, and aspirin tablets for dogs, to be adulterated.
The CGMP violations cited in the Warning Letter included: failure to conduct a thorough investigation of unexplained discrepancies for the failure of a batch or any of its components to meet any of its specifications; failure to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process materials and drug products; failure to establish written specifications for active ingredient and excipient components used in drug products; failure to have an individual inventory record of each component and a reconciliation of the use of each lot of such component; and failure to maintain a written record of equipment cleaning, maintenance, and use that includes the date and time of usage.
Aquaculture Drug Repacking Operations
On July 11, 2002, FDA's New Orleans District Office issued a Warning Letter to the president of B.L. Mitchell, Inc., Leland, Mississippi. An inspection of this aquaculture drug repacking operations on April 30 May 2, 2002, disclosed significant deviations from the CGMP regulations for pharmaceuticals. The Warning Letter cited the following CGMP violations: failure to test incoming bulk iodine disinfectant, nitrofurazone, and container closures to meet product specifications; failure to have a written testing program to assess the stability characteristics of your nitrofurazone products; failure to maintain master packaging and labeling control records; and, failure to establish written procedures for packaging and labeling control or cleaning and maintenance of equipment, including utensils. In addition, the firm's nitrofurazone product did not have the required caution statement.
Condemnation and Permanent Injunction for Veterinary Pharmacy, Corp.
Firm Found Compounding
Unapproved New Animal Drugs
U.S. v. Article of Drug for Veterinary Use...Veterinary Pharmacy Corp., et al., (D. Minn.) On February 28, 2002, a U.S. District Judge signed a Consent Decree of Condemnation and Permanent Injunction against a veterinary pharmacy and two corporate officers, as well as the drugs seized in this action. The seized drugs, intended for administration to food-producing animals, are unapproved new animal drugs that were compounded from bulk active ingredients. Such compounding violates the Animal Medicinal Drug Use Clarification Act's (AMDUCA) implementing regulations. The Decree orders the defendants to destroy the seized drugs and enjoins them from engaging in compounding activities that fail to conform to the AMDUCA regulations.
Horse Owner Pleads Guilty
United States v. David F. Novak (E.D. Michigan) On January 16, 2002, David Novak entered a guilty plea during the second day of a jury trial to charges of selling human and animal prescription drugs without a prescription. Novak, who owns, trains, and races horses, sold these drugs to an undercover agent believing that the agent intended to use the drugs to illegally affect his horses' performance in horse races.