Inspections, Compliance, Enforcement, and Criminal Investigations
Parreiro-Pinheiro & Sons Dairy 07-Sep-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Via Federal Express
Our Reference: 2954479
September 7, 2001
Michael T. Parreiro-Pinheiro, Co-owner
Parreiro-Pinheiro & Sons Dairy
13881 Road 120
Tipton, CA 93272
Dear Mr. Parreiro-Pinheiro:
A tissue residue report received by the Food and Drug Administration (FDA) from the
United States Department of Agriculture (USDA) reported the presence of an illegal
drug residue in a dairy cow that originated from your dairy. As a follow-up to USDA?s
finding, our investigator performed an inspection of your dairy operation located at
13881 Road 120, Tipton, CA, on August 9 and 10, 2001. The inspection revealed
serious violations of Section 402 and 501 of the Federal Food, Drug, and Cosmetic Act
A food is adulterated under Section 402(a)(2)(C)(ii) of [he Act if it contains a new
animal drug that is unsafe within the meaning of Section 512. On June 13, 2001, you
consigned a dairy cow, identified with back tag number 4231 (USDA laboratory report number 419067), to be sold for human food through [redacted] USDA analysis of tissue samples collected horn that calf identified the presence of the drug penicillin in the liver at 0.35 parts per million (ppm), and in the kidney at 0.86 ppm. Presently, the tolerance level for penicillin in the uncooked edible tissues of cattle is 0.05 ppm.
A food is adulterated under Section 402(a)(4) of the Act "if it has been prepared,
packed, or held under insanitary conditions . ..whereby it may have been rendered
injurious to health. " As it applies in this case, "insanitary conditions" means that you
hold animals which are ultimately offered for sale for slaughter as food under conditions which are so inadequate that medicated animals bearing possibly harmful drug residues are likely to enter the food supply. For example, our investigator noted the following:
1. You lack inadequate system for determining tie medication status of animals you
offer for slaughter. You are not keeping medication records specifying the dosage
administered for all drugs and the pre-slaughter withdrawal time.
2. You lack an adequate system for assuring that drugs are used in a manner not
contrary to the directions contained in their labeling or your veterinarian?s
3. You lack an adequate inventory system for determining the quantities of drugs used
to medicate your cows and calves.
You are adulterating the drug Pfizer Pfi-Pen G brand of penicillin G procaine within the
meaning of Section 501(a)(5) of the Act, in that it is a new animal drug within the
meaning of Section 201(v) of the Act, and is unsafe within the meaning of Section 512
of the Act sine-e it is not being used in accordance with the labeled directions. Pfi-Pen
G labeling prescribes a dosage of 1 ml per 100 pounds of body weight with no more
than 10 ml administered to any given injection site. Your practice of administering one
35 ml injection per day at one site results in a dosage in excess of that allowed in the
labeling. This overdosing presents a possibility that illegal residues will occur and is
the likely cause of the illegal residues found in the animal you consigned for slaughter.
Failure to comply with the label instructions on drugs you use to treat your animals
presents the likely possibility that illegal residues will occur and makes the drugs unsafe
for use. We request that you take prompt action to ensure that animals which you offer
for sale as human food will not be adulterated with drugs or contain illegal residues.
Introducing adulterated foods into interstate commerce is a violation of Section 301(a)
of the Act. Causing the adulteration of drugs after receipt in interstate commerce is a
violation of Section 301(k) 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 offered an adulterated animal for sale to a slaughter facility where it
was held for sale in interstate commerce is sufficient to make you responsible for
violations of the Act.
This 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. Failure to achieve prompt
corrections may result in enforcement action without further notice, including seizure
You should notify our office in writing, within fifteen (15) working days of the receipt
of this letter, of the specific steps you have taken to correct these violations and preclude 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 address each discrepancy brought to your attention during the inspection and in this letter, and should include copies of any documentation demonstrating that corrections have been made. Please direct your reply to Russell A. Campbell, Compliance 1431 Harbor Bay Parkway, Alameda, CA Officer, Food and Drug Administration, 94502.
Dennis K. Linsley