Letter to Kasel Associates Industries, Inc. - Notification of Opportunity to Initiate a Voluntary Recall

Letter to Kasel Associates Industries, Inc. - Notification of Opportunity to Initiate a Voluntary Recall – http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/UCM341491.pdf



DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service  Food and Drug Administration
Silver Spring, Maryland 20993
February 13, 2013
VIA HAND DELIVERY
Notification of Opportunity to Initiate a Voluntary Recall
Raymond J. Kasel, President

Kasel Associates Industries, Inc.

3315 Walnut St.

Denver, CO 80205

Dear Mr. Kasel:

Pursuant to section 423 'of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
3501), as amended by the FDA Food Safety Modernization Act, the U.S. Food and Drug
Administration (FDA) is providing your firm, Kasel Associates Industries, Inc. (Kasel), with an
opportunity to voluntarily cease distribution and conduct a recall of pet treat products
manufactured by your firm from April 20, 2012 through September 19, 2012. Section 423(a) of
the FD&C Act provides in relevant part that if FDA "determines ...that there is a reasonable
probability that an article of human or animal food (other than infant formula) is adulterated
under section 402 or misbranded under section 403(w) and the use of or exposure to such article
will cause serious adverse health consequences or death to humans or animals," before taking
further action under section 423 of the FD&C Act, FDA must offer the responsible party the
opportunity to voluntarily cease distribution and recall such articles (21 U.S.C. 3501(a)).1

As discussed further below, FDA has determined that for those pet treats manufactured at your
Denver facility from April 20, 2012 through September 19, 2012, which bear the lot codes
BESTBY20APR2014 to BESTBY030CT2014 for products with a two year expiry, or
BESTBY20APR2013 to BESTBY030CT2013 for products with a one year expiry (collectively,
affected pet treats), there is a reasonable probability that such products are adulterated under
section 402(a)(1)2 and (a)(4i ofthe FD&C Act (21 U.S.C. 342(a)(l) and (a)(4)) and a reasonable
1 The term "responsible party" is defmed in section 417 of the FD&C Act and refers to the person who submits the registration for a food facility that is required to register under section 415(a) of the FD&C Act (21 U.S.C. 350d), at which the food at issue is manufactured, processed, packed or held. On February 4, 2004, you registered Kasel with FDA pursuant to section 415(a) ofthe FD&C Act (21 U.S.C. 350d(a)). As such, this letter is directed to you as the responsible party.
2 Under section 402(a)(l) of the FD&C Act, a food shall be deemed adulterated if"it bears or contains a poisonous or deleterious substance which may render it injurious to health."