Inspections, Compliance, Enforcement, and Criminal Investigations
Tejas Industries Inc. 6/1/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
June 1, 2010
RETURN RECEIPT REQUESTED
Garth Merrick, CEO and Owner
Tejas Industries Inc.
110 Merrick Lane
Hereford, Texas 79045
Dear Mr. Merrick:
On December 2, 2009, FDA collected a sample of Merrick Beef Filet Squares manufactured by your Plainview, Texas facility and repackaged by your Hereford, Texas facility. Analysis of this dog chew revealed the product to be contaminated with Salmonella meleagridis. Representatives of the Food and Drug Administration (FDA) conducted inspections of your pet treat manufacturing facility located at 901 County Rd Y, Plainview, Texas 79073, on December 29-31, 2009, and your pet treat packaging facility located at 1977 E US Highway 60, Hereford, Texas 79045 on December 28-29,2009 and on January 13-14, 2010. These inspections confirmed that you offered pet treats for sale as food that were adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(1) and 402(a)(4) of the Act, 21 U.S.C. 342(a)(4). You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.qov.
Pet treats bearing or containing Salmonella spp., including Salmonella meleagridis, a known animal and human pathogen posing an acute danger to human and or animal health, are considered adulterated within the meaning of section 402(a)(1) of the Act, 21 U.S.C. 342(a)(1). A food, including food for animals, is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4), if it has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or may have been rendered injurious to health. Our inspections revealed that the manufacturing processes used by your firm to manufacture pet treats are not controlled and that contamination of these products may occur through inadequate treatment or through recontamination of the treated products due to improper storage or handling after processing.
Specifically, your firm could not provide evidence that your manufacturing processes eliminate pathogens such as Salmonella during processing because your firm does not consistently monitor critical factors in the process such as time and temperature; nor could you provide evidence demonstrating that recontamination was not likely to occur post-processing. Further, your firm could not provide evidence supporting the adequacy of your in-house sampling and testing program, for example, explaining the location and number of samples collected for each lot of finished product.
We recognize that your firm initiated a voluntary recall of Merrick Beef Filet Squares by letter to your customers dated January 11, 2010. The recall was initiated following FDA sampling and your firm's internal sampling, both of which revealed the presence of Salmonella. However, your recall strategy may be determined to be ineffective to the consumer level for the following reasons:
• Your firm delayed your public communication to alert consumers who may have the recalled product in their possession until after FDA issued an FDA Health Alert on January 14, 2010.
• Your recall communications to distributors, retailers, and consumers only included case lot coding 9323, which was different from the lot coding on some of the individual bags. Due to a labeling error, some of the affected bags were coded with the lot code 9333.
• Your recall letter did not identify the hazard involved. Your letter to wholesale and retail consignees indicated the product was recalled because it "may not have been processed properly." Recalls can be less effective if the recall communication does not concisely explain the reason for recall and the hazard involved.
FDA acknowledges the written responses we have received following our inspections. Separate letters, both dated January 18, 2010, were received addressing the observations made during the inspections we conducted at your locations in Plainview and Hereford, Texas. Although your letters indicate that your firm has taken steps to address our observations, they did not contain enough detail for us to evaluate. For example, your response letters did not include a copy of your validation protocol. We recommend that your validation study, in addition to establishing a specific profile for each dryer, also account for process and product variation including fat content, initial product temperature, and product size and location. We also recommend validation of your rework process. The corrections your firm has implemented at both sites will be evaluated and verified during our next inspection. We also acknowledge your letter of January 29, 2010, discussing your views on the applicability of the Reportable Food Registry to this situation.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You should include in your response, documentation and useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your written reply should be directed to the Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204, Attention: Sherrie L. Krolczyk, Compliance Officer.
Reynaldo R. Rodriguez, Jr.
Dallas District Director