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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Vaqueria Paso Real 13-May-08

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

Public Health Service
Food and Drug Administration

 

San Juan District
Compliance Branch
466 Fernandez Juncos Avenue
San Juan, Puerto Rico 00901-3223

Telephone: 787-474-9500
FAX: 787-729-6658


May 13, 2008
 

WARNING LETTER
SJN-08-04

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

Eduardo Rivera, Owner
Vaqueria Paso Real
Carr. #2, Km 53.0
Sector La Bajura Paso Real
Manati, Puerto Rico 00674.
 

Dear Mr. Rivera:

An inspection of your dairy farm located at Carr. #2, Km 53.0, Sector La Bajura, Paso Real, Manati, Puerto Rico, conducted by a representative of the U.S. Food and Drug Administration (FDA) on December 20, 2007, and January 18, 2008, revealed that you caused the new animal drugs [redacted] and [redacted] and [redacted] to become unsafe under section 512(a) [21 U.S.C. §360b(a)] Federal Food, Drug, and Cosmetic Act(the Act) and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov

Our investigation found you adulterated the drugs [redacted] and [redacted] within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351 (a)(5)] when you failed to use these 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 [21 U.S.C. §360b (a)(4)] and (5)] and Title 21, Code of Federal Regulations Part 530(21 C.F.R. Part 530). Our investigation found that your extralabel use of [redacted] and [redacted] failed to comply with these requirements.

For example, you administered the [redacted] without following the withdrawal period set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use of [redacted] resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). In addition, you administered [redacted] of lactating dairy cows when the directions in the approved labeling states intravenous (in the vein) use only. The extralabel use of [redacted] is prohibited in lactating dairy cows under 21 C.F.R. 530.41(9). Furthermore, your extralabel use of [redacted] resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because your extralabel use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, the drugs were 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. § 351(a)(5)].

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. For example, your firm has an obligation to hold animals under conditions where food with potentially harmful drug residues will not enter the food supply.

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 sent to Carlos I. Medina, Compliance Officer, U.S. Food and Drug Administration, 466 Fernandez Juncos, San Juan PR 00901. If you have any questions about this letter, please contact Mr. Medina at 787-474-9539 and/or Email carlosi.medina@fda.hhs gov.

Sincerely yours,

/S/

Maridalia Torres
District Director
San Juan District