Inspections, Compliance, Enforcement, and Criminal Investigations
Maria Medeiros Dairy 26-Jul-05
Department of Health and Human Services
Public Health Service
San Francisco District
Our Reference : 3003687167
Via Federal Express
26 July, 2005
Mr. Melvin Medeiros, Owner
Maria Medeiros Dairy
632 East Riverdale Avenue
Laton, California 93242-9751
Dear Mr. Medeiros:
A tissue residue report received by the Food and Drug Administration (FDA) from the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) reported the presence of illegal drug residues in a cow that originated from your dairy located at 632 East Riverdale Avenue, Laton, California. As a follow-up to USDA/FSIS finding, our investigators performed an inspection of your dairy operation on March 10th, March 14th, and April 21st, 2005. This inspection confirmed that you offered an animal for sale for slaughter as food that was adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 342(a)(2)(C)(ii)]. In addition, your extralabel, use of [redacted] caused within the meaning of Section 501(a)(5) of the Act [21USC 351(a)(5)].
On December 3, 2004, you sold a dairy cow identified with back tag number [redacted] subsequently identified with USDA/FSIS retain tag #52551306, for slaughter as human food. USDA/FSIS analysis of tissue samples (USDA/FSIS Sample #44260) collected from that animal identified the presence of the drug penicillin in the kidney at 0.26 parts per million (ppm). The tolerance level for penicillin in the uncooked edible tissues of cattle is 0.05 ppm (Title 21, Code of Federal Regulations (CFR), Part 556.510). The presence of penicillin above this level causes the edible tissues from this animal to be adulterated under Section 402(a)(2)(C)(ii) of the Act.
You should be aware that it is not necessary for you to have personally shipped an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you caused the adulteration of an animal that was sold to a slaughter facility that ships in interstate commerce is sufficient to hold you responsible for violations of the Act.
You also adulterated the drugs [redacted] within the meaning of Section 501(a)(5) of the Act when you failed to use the drugs in conformance with their 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) and 512(a)(5) of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of certain new animal drugs failed to comply with these requirements.
For example, you routinely inject, per day [redacted] to [redacted] ml ([redacted] to [redacted] units) of the [redacted] at a single intramuscular injection site for dairy cows weighing approximately 1400 to 1600 pounds, even though the manufacturer's labeling directs that no more than 10 ml be administered to any given injection site in livestock, and that the drug be administered at a rate of 3,000 units per pound of body weight ( 1 ml per 100 lbs). In addition, you use this drug for intrauterine infusions despite the fact that the a roved labeling states that the drug is for intramuscular use only. You also use [redacted] brand for intrauterine infusions in dairy cattle even though its approved labeling states that the drug is for intravenous administration only and should not be used in lactatin dairy cattle. The manufacturer's labeling for [redacted] indicates that it is to be administered by way of the animal's contrary to these directions, you used this drug for intrauterine infusions. You engaged in the extralabel use of these three drugs without the supervision of a licensed veterinarian, in violation of 21 CPR 530.11(a). Furthermore, your extralabel use of penicillin resulted in an illegal drug residue, in violation of 21 CFR 530.11(c) . Because your extralabel use of these drugs was not in compliance with 21 CFR Part 530, the drugs are unsafe under section 512(a) of the Act [21 U.S.C. 360b(a)] and your use caused them to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. 301(a)(5)].
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, such as seizure and/or injunction, without further notice.
The above is not intended to be an all-inclusive list of violations. It is your responsibility to ensure that all requirements of the Act are being met.
Within fifteen (15) working days of receiving this letter, you should notify our office in writing of the specific steps you have taken to correct these violations and prevent their recurrence. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which corrections will be completed. Your response should include copies of any documentation demonstrating that corrections have been made. Please direct your reply to Warren E. Savary, Compliance Officer, United States Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, California 94502.
Barbara J. Cassens
San Francisco District