Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caed-1_05-cv-00900/USCOURTS-caed-1_05-cv-00900-0/pdf.json

Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: Civil Miscellaneous Case

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McGREGOR W. SCOTT

United States Attorney

KIRK E. SHERRIFF

Asst. United States Attorney

Federal Building, Rm. 3654

1130 "O" Street

Fresno, CA 93721

Telephone: (559) 498-7272

Attorneys for Plaintiff

United States of America

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF CALIFORNIA

UNITED STATES OF AMERICA,

Plaintiff,

v.

CARL M. SOUSA and WHITE RIVER

DAIRY, a California company,

Defendants.

______________________________

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Case No. 1:05-CV-00900 OWW DLB

CONSENT DECREE OF PERMANENT

INJUNCTION

Plaintiff, the United States of America, by its undersigned

attorneys, having filed a Complaint for Injunction against

Defendants Carl M. Sousa and White River Dairy, a California

company, and Defendants having appeared and consented to the

entry of this Consent Decree of Permanent Injunction (the

"Decree"), without contest and before any testimony has been

taken, and the United States of America having consented to this

Decree; 

IT IS HEREBY ORDERED, ADJUDGED, AND DECREED that:

I. This Court has jurisdiction over the subject matter and

over all parties to this action.

II. The Complaint for Injunction states a cause of action 

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against Defendants under the Federal Food, Drug, and Cosmetic

Act, 21 U.S.C. §§ 301 et seq. (the "Act").

III. Defendants and each and all of their agents,

representatives, employees, attorneys, successors, assigns, and

any and all persons in active concert or participation with any

of them who have received notice of this Decree, are hereby

permanently restrained and enjoined, under the provisions of 21

U.S.C. § 332(a), and the inherent equity authority of this Court,

from directly or indirectly introducing or causing to be

introduced into interstate commerce, and delivering or causing to

be delivered for introduction into interstate commerce, any

article of food within the meaning of 21 U.S.C. § 321(f), and

administering to animals any new animal drug, within the meaning

of 21 U.S.C. § 321(v), while such drug is held for sale after

shipment in interstate commerce, unless and until:

A. Defendants have established and implemented a system

ensuring that each of the animals that they acquire,

purchase, hold, transport, sell, or consign is

individually and permanently identified, by tag number;

B. Defendants have established and implemented a written

record-keeping system that prevents them from selling,

consigning, or distributing any animals with illegal

new animal drug residues. This system shall include,

but not necessarily be limited to, the keeping of

written records on every animal to which Defendants

administer drugs. These records shall include, at

minimum: (1) the identity of each animal that

Defendants medicate; (2) the date of each

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administration of medication to each animal; (3) the

identity of each drug used; (4) the dosage of each drug

used; (5) the route of administration of each drug

used; (6) the lawful written order of a licensed

veterinarian within the context of a veterinarianclient-patient relationship for each drug used; (7) the

name of the person administering each drug; (8) the

proper withdrawal period for each drug used; (9) the

date such withdrawal period will terminate for each

drug used; (10) the date each medicated animal is

shipped for slaughter or leaves Defendants' control;

and (11) the name and address of the purchaser,

receiver, or consignee of each medicated animal that is

shipped for slaughter or leaves Defendants' control;

C. Defendants have established and implemented a system

ensuring that their use of new animal drugs conforms to

the use approved by the United States Food and Drug

Administration ("FDA") as contained in the drug's

approved labeling or to the lawful written orders of a

licensed veterinarian, so long as those orders do not

result in illegal residues. This system shall include,

but not be limited to, measures to ensure that the

following will not occur: (1) administration of drugs

in excess of the approved dosage, unless such

administration is in accordance with the lawful written

orders of a licensed veterinarian within the context of

a valid veterinarian-client-patient relationship and is

in compliance with 21 C.F.R. Part 530; (2) sale for

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slaughter of medicated animals before the expiration of

the relevant withdrawal period; and (3) use in

Defendants' animals of drugs not approved for use in

that species or not approved for the disease or other

condition for which the animal is being treated, unless

such use is in accordance with the lawful written

orders of a licensed veterinarian within the context of

a valid veterinarian-client-patient relationship and is

in compliance with 21 C.F.R. Part 530;

D. Defendants have established and implemented a drug

inventory and accountability system that prevents them

from selling, consigning, or delivering any animals

with illegal new animal drug residues. This system

shall include a written record for each drug that

Defendants purchase or receive for use in medicating

any of their animals, which record shall include, but

not be limited to: (1) the name of the drug; (2) the

date of purchase or receipt of the drug; (3) the

quantity, strength, and form of the drug purchased or

received; (4) the name and address of the supplier or

seller of the drug; (5) the date each drug is

administered; and (6) the amount and method of each

administration. In addition, the inventory and

accountability system shall include periodic checks of

inventory and records to ensure that records accurately

document the drugs currently on hand and the

disposition of all drugs purchased or received,

including whether the drugs have been administered;

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E. Defendants have established and implemented a

quarantine or segregation system that ensures ready

distinction between medicated and unmedicated animals

and that prevents Defendants from selling, consigning,

or delivering for slaughter for use as food any animals

with above tolerance new animal drug residues;

F. Defendants have established and implemented a system

that ensures that each animal that has been medicated

is not directly or indirectly sold, consigned, or

delivered for immediate or ultimate slaughter until the

withdrawal period (specified either in the approved

labeling or the lawful written orders of a licensed

veterinarian, for each drug used on such animal) has

expired. This system shall also ensure that each

purchaser, receiver, or consignee receives, prior to

accepting any animal, a written statement from

Defendants certifying that any animal that has been

medicated has also been withdrawn for the appropriate

time period or that the animal has not been medicated. 

This written statement must also include the date(s) on

which the animal was medicated, each drug with which

the animal was treated, the required withdrawal period

for each drug, and the date(s) on which the withdrawal

period(s) expired. Defendants shall, prior to selling

any animal, obtain the signature of the purchaser,

receiver, or consignee documenting receipt of the

statement from Defendants. Defendants shall keep, as

part of their records, a copy of the signed written

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statement described in this paragraph;

G. Defendants have established and implemented a system

that identifies the source of each animal that they

purchase or transport and documents whether such animal

has been medicated, the date of such medication, the

drug used, and the withdrawal period for such drug;

H. Defendants have reported to FDA in writing the steps

they have taken to comply with paragraphs III(A)-(G);

I. Within twenty (20) calendar days after receiving the

written report required in paragraph III(H), or as soon

as reasonably practicable, FDA representatives shall

inspect Defendants' operations, including all records

relating to the medication, purchase, sale,

consignment, and distribution of food-producing

animals; and

J. FDA has notified Defendants, in writing, that they

appear to be in compliance with the requirements of

paragraphs III(A)-(H) of this Decree. FDA shall notify

Defendants regarding its compliance status within

thirty (30) calendar days after completion of its

inspection identified in paragraph III(I) of this

Decree, or as soon thereafter as is reasonably

practicable.

IV. Prior to obtaining written notification of compliance

from FDA as specified in paragraph III(J) above, Defendants may

administer medications as prescribed to an ill food-producing

animal that they own, but only after the animal has been examined

by a licensed, professional veterinarian and that veterinarian

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has diagnosed and prescribed the particular medication for that

animal. Defendants shall submit copies of the veterinarian's

diagnosis, prescription, and receipts for treatment or the

equivalent to FDA within ten (10) calendar days after treatment.

V. Defendants shall maintain all records described in

paragraph III for each animal for a period of at least two (2)

years after the date the animal is sold, consigned, or delivered

for slaughter. These records shall be made available immediately

to FDA upon request for purposes of inspection and copying.

VI. Within twenty (20) calendar days after the entry of

this Decree, Defendants shall: (a) provide a copy of the Decree,

by personal service or by certified mail, return receipt

requested, to each and all of Defendants' agents,

representatives, employees, attorneys, successors, assigns, and

any and all persons in active concert or participation with any

of them, and all persons to whom Defendants have sold, consigned,

or delivered any cattle or calves for slaughter within one year

preceding the date of entry of the Decree; and (b) explain the

terms of the Decree to each employee.

VII. Within twenty (20) calendar days after the entry of

this Decree, Defendants shall provide the Director, FDA San

Francisco District Office, at the address set forth in paragraph

XVI, and to Plaintiff's attorneys, an affidavit from a person

with personal knowledge of the fact stated therein, stating the

fact and manner of Defendants' compliance with paragraph VI and

identifying the names and positions of all persons who were

notified pursuant to paragraph VI.

VIII. After entry of the Decree, Defendants shall, within

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fifteen (15) calendar days of employment of any new employee at

Defendants' dairy operation: (a) provide a copy of the Decree, by

personal service or by certified mail, return receipt requested,

to all such employees; and (b) explain the terms of the Decree to

all such employees.

IX. After Defendants receive written notification from FDA

as specified in paragraph III(J) above, Defendants and each and

all of their agents, representatives, employees, attorneys,

successors, assigns, and any and all persons in active concert or

participation with any of them, are permanently restrained and

enjoined from directly or indirectly doing or causing to be done

any of the following acts:

A. Introducing and delivering for introduction into

interstate commerce any article of food, within the

meaning of 21 U.S.C. § 321(f), that is adulterated

within the meaning of 21 U.S.C. §§ 342(a)(2)(C)(ii) or

342(a)(4);

B. Administering to any food producing animal any article

of drug, within the meaning of 21 U.S.C. § 321(g),

unless such administration is in a manner that strictly

conforms to such drug's labeled indications and

conditions for use or is by or on the lawful written

order of a licensed veterinarian within the context of

a valid veterinarian-client-patient relationship and is

in compliance with 21 C.F.R. Part 530;

C. Doing any act with respect to any article of drug,

within the meaning of 21 U.S.C. § 321(g), or new animal

drug within the meaning of 21 U.S.C. § 321(v), if such

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act is done while such drug is held for sale after

shipment in interstate commerce and results in such

drug being adulterated within the meaning of 21 U.S.C.

§ 351(a)(5); and

D. Failing to implement and continuously maintain the

requirements of this Decree.

X. Representatives of FDA shall be permitted, without

prior notice and as and when FDA deems necessary, to make

inspections of Defendants' dairy operations, including any new

locations, and any facility or location at which Defendants hold

or store drugs used to treat animals, including food producing

animals, and to take any other measures necessary to monitor and

ensure continuing compliance with the terms of this Decree. Such

inspections may, at FDA's discretion, include the taking of

photographs and samples and the examination and copying of all

records that relate to the drug treatment and the holding,

delivery, sale, consignment, or distribution of animals on the

premises. Such inspections shall be permitted upon presentation

of a copy of this Decree and appropriate credentials. Such

inspection authority granted by this Decree is apart from, and in

addition to, the authority to make inspections under the Act, 21

U.S.C. § 374.

XI. Defendants shall promptly provide any information or

records to FDA regarding the sale, consignment, delivery, or

medication of any animals upon request.

XII. Defendants shall reimburse FDA for the costs of

conducting and evaluating all inspectional, laboratory and

analytical, and other work that FDA deems necessary to evaluate

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Defendants' compliance with any part of this Decree at the

standard rates prevailing at the time the activities are

accomplished. As of the date of entry of this Decree, these

rates are: $73.55 per hour and fraction thereof per

representative for inspection and supervision work other than

laboratory and analytical work; $88.15 per hour and fraction

thereof per representative for laboratory and analytical work;

38.5 cents per mile for travel expenses; and reasonable

subsistence expenses where necessary. In the event that the

standard rates generally applicable to the FDA supervision of

court-ordered compliance are modified, these rates shall be

increased or decreased without further order of the Court.

XIII. If any Defendant violates this Decree and is found in

civil or criminal contempt thereof, that Defendant shall, in

addition to other remedies, reimburse the Plaintiff for its

attorneys' fees (including overhead), investigational expenses,

expert witness fees, and court costs relating to such contempt

proceedings.

XIV. If, based on the results of any inspection or analysis

conducted after the inspection described in paragraph III(I), or

any other information, FDA finds that any Defendant is not in

compliance with the Act or the requirements of this Decree, FDA

may notify Defendants in writing of the non-compliance and may

require that Defendants immediately cease selling or delivering,

or causing to be sold or delivered, animals for slaughter for use

as food, and immediately cease medicating animals in a manner

inconsistent with drugs' labeled indications and conditions for

use or the lawful written orders of a licensed veterinarian

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within the context of a valid veterinarian-client-patient

relationship and FDA's regulations set forth in 21 C.F.R. Part

530. Upon receipt of such notification, Defendants shall

immediately and fully comply with the terms of the notice. Any

cessation of operations as described above shall continue until

receipt by Defendants of written notification from FDA that

Defendants appear to be in compliance with the terms of this

Decree, the Act, and all applicable regulations.

XV. Defendants shall notify FDA at least thirty (30)

calendar days before any change in ownership, name, or character

of the business that occurs after the entry of this Decree, such

as reorganization, relocation, assignment, or sale of the

business that may affect compliance obligations arising out of

this Decree. Defendants shall serve a copy of this Decree on any

prospective successor or assignee at least thirty (30) calendar

days prior to such sale or change of business, and shall furnish

to FDA and to the Plaintiff's attorneys an affidavit of

compliance with this paragraph within fifteen (15) calendar days

of such sale or change of business.

XVI. All notifications, correspondence, and communications

to FDA required by the terms of this Decree shall be submitted to

the Director, San Francisco District Office, 1431 Harbor Bay

Parkway, Alameda, California 94502-7070.

XVII. All decisions specified in this Decree shall be vested

in the discretion of FDA and shall be final. FDA's decisions

under this Decree shall be reviewed, if necessary, under the

arbitrary and capricious standard set forth in 5 U.S.C.

§ 706(2)(A) and shall be based exclusively upon the written

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record that was before FDA at the time of the decision. No

discovery may be had by either party.

XVIII. No sooner than five (5) years after entry of this

Decree, Defendants may petition this Court for an order

dissolving this Decree. If Defendants have maintained to FDA's

satisfaction a state of continuous compliance with this Decree,

the Act, and all applicable regulations during the five (5) years

preceding Defendants' petition, Plaintiff will not oppose such

petition.

XIX. This Court retains jurisdiction of this action and the

parties hereto for the purpose of enforcing and modifying 

this Decree and for the purpose of granting such additional

relief as may be necessary and appropriate.

IT IS SO ORDERED.

Date: _July 13, 2005___

/s/ OLIVER W. WANGER

_____________________________

UNITED STATES DISTRICT JUDGE

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Entry Consented to:

FOR DEFENDANTS FOR PLAINTIFF

McGREGOR W. SCOTT

United States Attorney

/s/ Carl M. Sousa

(signature on file) By: /s/ Kirk E. Sherriff 

CARL M. SOUSA KIRK E. SHERRIFF

on behalf of defendant Assistant U.S. Attorney

WHITE RIVER DAIRY

Of Counsel:

ALEX M. AZAR II

General Counsel

/s/ Carl M. Sousa

(signature on file) 

CARL M. SOUSA, SHELDON BRADSHAW

in his individual capacity Chief Counsel

Food and Drug Division

ERIC M. BLUMBERG

Approved as to form: Deputy Chief Counsel for

Litigation

KAHN, SOARES & CONWAY, LLP MICHELE LEE SVONKIN

Trial Attorney

U.S. Dept. of Health &

/s/ John V. Ohnstad, Jr. Human Services

(signature on file) Office of the General

JOHN V. OHNSTAD, JR. Counsel

5600 Fishers Lane

Attorneys for defendants Rockville, MD 20857

CARL M. SOUSA and (301) 827-2803

WHITE RIVER DAIRY

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