Department of Health and Human Services Public Health Service
Food and Drug Administration
Atlanta District Office
60 8th Street, N.E.
Atlanta, GA 30309
April 12, 2006
VIA FEDERAL EXPRESS
Schell and Kampeter Inc.
103 N. Olive Street
Meta, MO 65058
Dear Mr. Schell:
An inspection of your pet food manufacturing facility located at 100 Wood Trail Drive in Gaston, South Carolina was conducted by a Food and Drug Administration (FDA) investigator from December 21, 2005 through January 19, 2006. Our investigation determined that your firm manufactures various dog and products under several labels including Diamond, Country Value, Professional, and [redacted].The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). Our investigator documented that your firm manufactured a number of lots of dog food between September 1, and November 30, 2005, which were released for distribution in interstate commerce, that were adulterated under section 402(axl) of the Act [21 U.S.C. § 342(a)(1)] because they contained a poisonous or deleterious substance (aflatoxin) which may render them injurious to health.
In addition, these lots of pet food were adulterated under section 402(a)(4) [21 U.S.C.§ 342(a)(4)] of the Act. The inspection revealed that you failed to implement appropriate controls at the Gaston facility to prevent the adulteration of this pet food. The investigator also found that Gaston plant personnel failed to follow established procedures, which, if followed, could have prevented these violative lots from being distributed.
A review of the aflatoxin testing results performed on retained corn samples by an outside test laboratory revealed that four incoming shipments of corn that should have been rejected were instead accepted at the Gaston facility. Testing of the retained samples from these four shipments revealed aflatoxin levels between 90 and 1851 ppb. The Incoming Ingredient Inspection forms for three of these lots indicate that the product was tested and found to contain less than 20 ppb of aflatoxin. The fourth inspection form does not indicate whether the lot was tested at all. In fact, twelve of the [redacted] Incoming Ingredient Inspection forms reviewed from the September-October 2005 time frame -did not indicate that an a,flatoxin test had been performed.
A comparison of the analytical results from an outside testing laboratory on retained samples and your in-house testing results revealed some discrepancies that raise concerns as to the adequacy of the test you were using. Four corn shipments that were found to contain less than 20 ppb at the Gaston plant were found to have aflatoxin levels of 90 to 1851 ppb by the outside lab. Two com shipments found to contain over 20 ppb by in-house analysis were found to contain 2 to 4 ppb by the outside lab. Due to a lack of documentation, the investigator could not determine whether the positive and negative controls were utilized for the in-house testing.
Your Gaston facility did not follow significant quality control procedures that were in place to prevent aflatoxin contamination. Although retention samples were supposed to be maintained for incoming corn shipments, over 50% of the retained samples were missing for September- November, 2005. Quality control personnel did not ensure these retention samples were collected. Your firm also has procedures in place calling for incoming ingredients to be analyzed by near infrared reflectance spectroscopy (NIR). For example, incoming whole corn was to be tested for several characteristics, including moisture. There was no documentation of any NIR test results for whole corn for 2005.
Our inspection also revealed that the waste or salvaged material from pet food production (scrapes) was being sold to a local hog farmer in bulk. Some of the pet food manufactured at your plant contains protein derived from mammalian tissues. This scrape product, which may contain prohibited material, was not labeled with the statement \"Do not feed to cattle or other ruminants,\" as required by Title 21, Code of Federal Regulations (21 CFR), 589.2000(d)(1) (21 CFR 589.2000(d)(1)). This regulation is intended to help prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). This labeling deviation causes the pet food scrapes you distributed to be misbranded within the meaning of section 403(a)(1) [21 U.S.C. § 343(a)(1)] of the Act.
At the conclusion of the inspection, the Inspectional Observations, Form FDA 483, was issued to and discussed with Robert R. Petruzzi, Plant Manager. A copy of the Form FDA 483 is included for your review in this letter. Neither the Form FDA 483 nor this letter is intended as an all-inclusive list of violations at your firm. As a manufacturer of pet foods, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law at all of your facilities.
We note that you initiated same corrective actions during the inspection, including undertaking a voluntary recall. We also acknowledge receipt of a response to the FDA 483, dated January 27, 2006, from Robert Petruzzi. The response appears to set out actions that would adequately address the violations. Please provide us with copies of a11 new procedures and protocols implemented at your firm. These copies should be sent to Philip S. Campbell, Compliance Officer, at the address noted in the letterhead. We will verify the adequacy of the corrective actions taken by your firm during a future inspection. If the actions have not adequately corrected the violations, we may initiate regulatory action without further notice. Such action includes, but is not limited to, seizure and/or injunction.
Mary A. Woleske, Director