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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Moon Glow Dairy 31-Aug-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 34542-7070
Telephone: 510-337-6700



VIA-FEDERAL EXPRESS

Our Reference: 1000135155

August 31, 2006

Louis R Calcagno, Co-owner
Carol S. Calcagno, Co-owner
Moon Glow Dairy
357 Dolan Road
Moss Landing, CA 95039

WARNING LETTER

Dear Mr. and Mrs. Calcagno:

An investigation of your dairy operation located at 357 Dolan Road, Moss Landing, California, conducted by a representative of the U.S. Food & Drug Administration (FDA) on May 4, 11, and 15, 2006, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. §342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The investigation also revealed that you caused the new animal drug flunixin meglumine (Suppressor brand) to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. §351(a)(5)] of the Act and unsafe within the meaning of section 512 [21 U.S.C. § 360b] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

On or about December 20, 2005, you consigned a dairy cow (ear tag # [redacted]), identified with back tag number [redacted] to [redacted], in [redacted]. On December 20, 2005, this cow was sold through the sales yard and subsequently slaughtered by [redacted]. United States Department of Agriculture, Food Safety and Inspection Service (USDAIFSIS) analysis of tissue samples collected from that animal identified the presence of flunixin in the liver at 0.180 parts per million (ppm). A tolerance level for 'residues of flunixin has been established for the liver of cattle at 0.125 ppm as codified in Title 21, Code of Federal Regulations, Part 556.286 (21 C.F.R. 556.286). The presence of this drug in the liver of this dairy cow in this dairy cow in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete treatment records and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Act.

In addition, you adulterated the drug flunixin meglumine ([redacted] brand of Suppressor) within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance, with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of flunixin meglumine failed to comply with these requirements. For example, you administered flunixin meglumine ([redacted] brand of Suppressor) without following the route of administration, withdrawal period, and indications for use set forth in the approved labeling and you did so without following your veterinarian's instructions, in violation of 21 C.F.R. 530.10(a). Furthermore, your extralabei use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) [21 U.S.C.§ 360b(a)] of the Act and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.

In addition, our investigation revealed you routinely administer [redacted]cc's of penicillin G procaine (Agripharm brand of Pen-Aqueous) to your dairy cows. Label directions for penicillin G procaine (Agripharm brand of Pen-Aqueous) specify a dosage of 1 cc per 100 lbs of bodyweight and no more than 10cc's per injection site. Your extralabel use, however, did not comply with the applicable requirements because, for example, your extralabel use was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530; the drug was unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)) of the Act.

We also noted during our inspection;on you have the drug Baytril 100 (enrofloxacin) in your [redacted] which you use to treat your calves. Baytril 100 is not approved for use in cattle intended for dairy production or calves to be processed for veal. The term "cattle intended for dairy production" refers to all classes of cattle involved in the dairy farm operation including calves reared as dairy cow replacements, heifers, lactating and non-lactating (dry) dairy cows, and bulls maintained for breeding purposes. Moreover, the extralabel use of fluoroquinolones, including Baytril 100, in food animals is prohibited under 21 C.F.R. 530.41. The restriction on use of Baytril 100 in cattle intended for dairy production and calves to be processed for veal is based on human food safety concerns.

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law. We note that since 1999, USDA/FSIS has identified [redacted] other illegal tissue residues in [redacted] dairy cows and [redacted] calf from your operation.

You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be directed to Karen L. Robles, Consumer Safety Officer, Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, please contact Karen Robles at (91b) 930-3674 ext 14.

Sincerely,

/S/

Barbara J. Cassens
District Director
San Francisco District