Inspections, Compliance, Enforcement, and Criminal Investigations
Bioesl Packing Company, Inc. 14-Jun-06
Department of Health and Human Services
Public Health Service
Baltimore District Office
FEI : 3003730924
June 14, 2006
RETURN RECEIPT REQEUSTED
Mr. Jeffrey Burton; President
Boesl Packing Company, Inc.
2322 Belair Road
Baltimore, MD 21213
Dear Mr. Burton:
On March 10, 2006, the Food and Drug Administration (FDA) conducted an inspection of your facility located at 2322 Belair Road, Baltimore, Maryland. FDA has also reviewed your product labels and a brochure entitled "What Does Your Dog Krave." Based on information collected during our on-site inspection and review of this other information, we have determined that your product, "K-9 Kraving Dog Food," is a drug as defined in section 201(g) [21 U.S.C. § 321(g)] of the Federal Food, Drug, and Cosmetic Act (the Act) and a new animal drug as defined in section 201(v) of the Act. Your product is adulterated within the meaning of section 501 (a)(5) [21 U.S.C. § 351(a)(5)] of the Act, in that it is a new animal drug which is unsafe within the meaning of section 512(a)(1)(A) [21 U.S.C. § 360b(a)(1)(A)] of the Act. Under section 512(a)(1)(A) [21 U.S.C. § 360b(a)(1)(A)] of the Act, a new animal drug is considered to be unsafe unless there is an approved New Animal Drug Application (NADA) for the product.
In addition, FDA has determined that your facility is subject to the registration requirement in section 415 [21 U.S.C. § 350d] of the Act and our implementing regulation at Title 21, Code of Federal Regulations, Part 1, Subpart H. During our inspection of your facility on March 10, 2006, your representative was advised of this requirement. The failure to register a facility as required is a prohibited act under section 301(dd) [21 U.S.C. § 331(dd)] of the Act. Our records indicate that, to date, your facility has not been registered with FDA.
The therapeutic claims contained in your product brochures establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of a disease. Drug claims found in your product brochure include, but are not limited to:
. . . and allergy reductions are just a few of the benefits you can expect with this exceptional diet.
K-9 Kraving uses Olewo Carrots . . .The result is . . . a reduced risk of certain cancers. In addition, Olewo Carrots . . . stop diarrhea and contain distilled oils that help fight worms and parasites.
The above is not intended to be an all-inclusive list of violations. As a producer of animal food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the above violations and establish procedures whereby such violations do not recur. You must cease marketing "K-9 Kraving Dog Food" and file an application for a NADA, or remove the therapeutic claims from your product brochures. Furthermore, you must register your food manufacturing facility with FDA. Registration may be accomplished online at http://www.access.fda.gov.
Failure to promptly correct these deviations may result in regulatory action by FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
You should notify this office, in writing, within 15 working days of receiving this letter. Your response should include the specific steps you have taken or will take to correct the noted violations, including an explanation of each step being taken to identify and make corrections to ensure that similar violations will not recur. Please include any available documentation demonstrating that corrections have been made. Please submit your response to Randy F. Pack, Compliance Officer, Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland, 21215-3215. If you have additional questions, please do not hesitate to contact Mr. Randy F. Pack at 410-779-5454, ext. 417.