FDA Warning Letter To Company That Makes American Bullie Dog Chew Products
Posted on Tuesday, July 10th, 2007 at 4:39 am in Products & Services, National, Dogs, Recalls & Safety.
In April, Itchmo posted about a FDA salmonella contamination alert in American Bullie Dog Chew products.
In a follow-up to their salmonella contamination, a FDA warning letter dated June 11, 2007 was sent to T.W. Enterprises, the company that makes American Bullie Dog Chew products. The letter referenced the FDA inspections that were conducted on January 18 and 23.
During these inspections, the FDA not only found salmonella in the products, but they noted that the company had other violations. The company was found to be dipping their products in bleach.
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 warning letter gave T.W. Enterprises 15 days to correct their actions and comply with the Federal Food, Drug and Cosmetic Act.
We were completely blown away that a company would dip pet food products in bleach. We contacted the compliance officer to see if T.W. Enterprises had corrected their actions and complied with the act. We are still waiting for a response and will post it as soon as we hear from the officer.
The FDA warning letter to T.W. Enterprises:
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996
June 11, 2007
CERTIFIED MAIL
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
WARNING LETTER
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 http://www.fda.gov.
A sample of “AMERICAN BULLIE A .B . DOG CHEW, 6″ MEDIUM,â€