- Animal & Veterinary
- Neely Livestock
- Issuing Office:
- New Orleans District Office
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
October 6, 2014
WARNING LETTER NO. 2015-NOL-01
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Johnny K. Neely, Owner
4315 Woodbury Pike
Murfreesboro, Tennessee 37127-4752
Dear Mr. Neely:
On August 5, 12, and 13, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your livestock operation, located at 4315 Woodbury Pike, Murfreesboro, Tennessee. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act
(the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov
We found you offered for sale an animal for slaughter as food that was adulterated. Under Section 402(a)(2)(C)(ii) of the Act [21 United States Code (USC) 342(a)(2)(C)(ii)] a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under Section 512 of the Act (21 USC 360b). Further, under Section 402(a)(4) of the Act [21 USC 342(a)(4)] a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about April 15, 2014, you sold a pig (Retain Tag No: (b)(4) for slaughter as food. On or about April 17, 2014, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service, analysis of tissue samples collected from this animal identified the presence of penicillin in the muscle and kidney tissues and the presence of spectinomycin residue in the kidney tissue. FDA has established a tolerance of 0.0 ppm for residues of penicillin in the uncooked edible tissues of swine, as codified in Title 21, Code of Federal Regulations, Part 566.510(b), [21 CFR 556.510(b)]. FDA has not established a tolerance for residues of spectinomycin in the edible tissues of swine, as codified in 21 CFR 556.600. The presence of these drugs (penicillin and spectinomycin) in edible tissue from this animal causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act [21 USC 342(a)(2)(C)(ii)].
Our investigation also found you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you lack an adequate system to ensure animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues and you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of Section 402(a)(4) of the Act [21 USC 342(a)(4)].
We also found you adulterated the new animal drugs (b)(4) (penicillin G procaine injectable suspension, NADA 065-505) and (b)(4) (Lincomycin-Spectinomycin soluble powder, ANADA 200-380). Specifically, our investigation revealed you did not use (b)(4) and as directed by their approved labeling. Use of these drugs in this manner is an extra label use [21 CFR 530.3(a)].
The extra label use of approved animal or human drugs in animals is allowed under the Act only if the extra label use complies with Sections 512(a)(4) and 512(a)(5) of the Act [21 USC 360b(a)(4) and (5)] and 21 CFR 530 including the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found you administered (b)(4) (penicillin G procaine injectable suspension, NADA 065-505) to your pig (Retain Tag No: (b)(4)) without following the dose, as stated in the approved labeling. Your extra label use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extra label use of (b)(4) resulted in illegal residues, which is in violation of 21 CFR 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR 530, you caused the drug to be unsafe under Section 512(a) of the Act [21 USC 360b(a)] and adulterated within the meaning of Section 501(a)(5) of the Act [21 USC 351(a)(5)].
Our investigation also found you administered (b)(4) (Lincomycin-Spectinomycin soluble powder, ANADA 200-380) to your pig (Retain Tag No: (b)(4) without following the animal class or species as stated in the approved labeling. Your extra label use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extra label use of (b)(4) resulted in illegal residues (spectinomycin), which is in violation of 21 CFR 530.11(c). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR 530, you caused the drug to be unsafe under Section 512(a) of the Act [21 USC 360b(a)] and adulterated within the meaning of Section 501(a)(5) of the Act [21 USC 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 your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
FDA acknowledges the written response we received following our investigation. An undated letter was received by the New Orleans District Office on August 18, 2014. The hand written letter, addressing the observations made during the recent inspection conducted on August 5, 12, and 13, 2014, states you plan on making changes to your operations to prevent future violations. Although your letter indicates you will take steps to address our observations, you did not provide examples of the documents you intend on using nor did you specify how you would implement the changes to your operations. Based on your firm's history of residues, the effectiveness of your corrective measures can only be determined over time.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 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 15 working days of receiving this letter, 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 Rebecca A. Asente, Compliance Officer, to the address above. If you have any questions about this letter, please contact Compliance Officer Asente at (504) 832-1290 ext. 1104.
Kimberly L. McMillan
Acting District Director
New Orleans District
cc: Scott E. Seebohm, DVM, Deputy Director
United States Department of Agriculture
Food Safety and Inspection Service
Office of Policy and Program Development
Policy Development Division
1616 Capitol Ave, Suite 260
Omaha, NE 68102
Charles Hatcher, DVM
Tennessee Department of Agriculture-Animal Health
436 Hogan Road
Nashville, Tennessee 37220
Director, Regulatory Services
Tennessee State Dept. of Agriculture
440 Hogan Road
Nashville, Tennessee 3720