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

Telephone: 510-337-6700

Via Federal Express

Our Reference: 2954479

September 7, 2001

WARNING LETTER

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

(the 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

prescription labeling.

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

and/or injunction.

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.

Sincerely yours,

Dennis K. Linsley

District Director