Inspections, Compliance, Enforcement, and Criminal Investigations
T.W. Enterprises, Inc. 01-Jul-07
Department of Health and Human Services
Public Health Service
June 11, 2007
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 07-16
Ian W. McCauley, President
T.W. Enterprises, Inc.
7056 Portal Way, Bldg. N-2
Ferndale, Washington 98248
Dear Mr. McCauley:
An inspection at your facility located at 7056 Portal Way, Bldg. N-2, Ferndale, Washington, was conducted by a representative of the Food and Drug Administration (FDA) on January 18 and 23, 2007. This investigation confirmed that you offered pet treats for sale as food that were adulterated within the meaning of section 402(a)(1)[21 U.S.C. 342(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.
A sample of "AMERICAN BULLIE A .B . DOG CHEW, 6" MEDIUM," manufactured by your facility was collected and analyzed. FDA analysis of this dog chew revealed the product to be contaminated with Salmonella muenster. Salmonella, including Salmonella muenster, is a micro-organism that is known to be pathogenic to animals and humans. Dog chews bearing or containing Salmonella pose a danger to human and animal health and are adulterated within the meaning of Section 402(a)(1) [21 U.S.C. 342(a)(1)] of the Act.
The above may not be an all-inclusive list of your violations. As a manufacturer of dog and puppy chews, it is your responsibility to assure your products are in compliance with the Act. We acknowledge your actions in recalling all sizes of your dog and puppy chews. However, you should take prompt action to investigate the source of this contamination and establish controls to prevent future violations. Further shipment of adulterated food may result in regulatory action without further notice to you. These actions include, but are not limited to, seizure and/or injunction.
The inspection also revealed that it is a practice of your firm to allow pizzles to [redacted], then to submerge them in [redacted] of water containing [redacted] bleach for [redacted] hours. Household bleach is not approved for use in animal feeds. Firms or individuals who want to use a substance in feeds for a purpose for which the substance is either not generally recognized as safe (GRAS) or approved by the FDA as a food additive are required to first contact the FDA or file a food additive petition to establish the safety and utility of the substance for its intended use. The requirements for a food additive petition are specified in Title 21, Code of Federal Regulations, part 571 (21 CFR 571). A copy of the pertinent section of the Code is attached for your information
Please notify this office in writing, within fifteen (15) working days of receiving this letter of the steps you have taken to assure your products are in compliance with the Act. If corrective action cannot be accomplished in fifteen (15) working days, state the reason for the delay and the date by which corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Your response should be directed to Lisa M. Elrand, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington, 98021-4421.
If you have any questions regarding this letter, you may call Compliance Officer Elrand at (425) 483-4913.
Charles M . Breen