Inspections, Compliance, Enforcement, and Criminal Investigations
American Pecan Co. LLC 6/25/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
June 25, 2010
Return Receipt Requested
Rogelio A. Gonzales, President
American Pecan Co. LLC
P.O. Box 151
Yancey, Texas 78886
Dear Mr. Gonzales:
From January 11 to February 10, 2010, investigators from the U.S. Food and Drug Administration (FDA) conducted an inspection of your pecan repackaging facility located at 330 County Road 743, Yancey, Texas 78886. The inspection confirmed that you process ready-to-eat, raw pecans in 1 pound consumer size containers that were adulterated within the meaning of sections 402(a)(1) [21 U.S.C. 342(a)(1)] and 402(a)(4) [21 U.S.C. 342(a)(4)] 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.
On February 9,2010, FDA collected a sample (Sample 597164) of Pecan Pieces (Medium) in 1 pound packages, which are sold directly to consumers at your onsite retail store and through mail orders. Analysis of the sample revealed the product to be contaminated with Salmonella oranienburg (S. oranienburg). Salmonella, including S. oranienburg, is a micro-organism that is known to be pathogenic to humans. Ready-to-eat pecans containing Salmonella pose a danger to humans and are adulterated within the meaning of Section 402(a)(1). We acknowledge that your firm initiated a recall of the affected product on February 26, 2010.
The inspection also included the collection of environmental samples from various locations within your processing facility, including plywood flooring in the area where pecans are processed and packaged. FDA laboratory analyses of the environmental samples (FDA samples 570472 and 570473), found Salmonella spp. in seven subsamples taken from seven different locations within your facility. Each of these positive subsamples was further serotyped and six were determined to be Salmonella newport (S. newport), and one was determined to be Salmonella oranienburg (S. oranienburg).
Pulsed Field Gel Electrophoresis (PFGE) testing determined that the six isolates of S. newport were indistinguishable from one another. The recovery of an indistinguishable S. newport serotype pattern is significant because this indicates that Salmonella may have established a niche in your manufacturing facility, and further emphasizes the need for strict sanitation measures to ensure effective cleaning and sanitizing of food contact and non-food contact surfaces. Accordingly, FDA's analytical results for environmental samples cause your firm's ready-to-eat pecan products to be adulterated within the meaning of section 402(a)(4) of the Act, in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
A review of your product labels reveals violations of the Act and FDA's labeling regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). As a result of these violations, several of your products are misbranded within the meaning of section 403 of the Act [21 U.S.C § 343].
Your bulk pecan products, are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to declare a statement of identity in accordance with 21 CFR 101.3(a).
We note that several of your pecan products fail to bear a Nutrition Facts panel as required by 21 CFR 101.9. Your firm may be eligible to file for a small business nutrition labeling exemption for products which do not declare nutrient information, nutrient content or health claims on the labels, labeling or advertising. In accordance with 21 CFR 101.9(j)(18), a firm may qualify for this exemption if the firm has fewer than 100 full time employees and fewer than 100,000 units of a product are being sold in the United States, provided that the product labels, labeling, and advertising do not provide nutrition information or make a nutrient content or health claim. A firm is required to file an exemption notice each year with FDA unless the firm has fewer than 10 full time equivalent employees. We have no record of your firm having filed a Small Business Nutrition Labeling Exemption Notice.
This letter does not list all the violations at your facility. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110), including the observation of painted plywood floors in areas where pecans are sorted, cut, packaged, and stored. FDA laboratory analysis of an environmental sample collected from your plywood floor confirmed the presence of S. newport. Because plywood floors are not easily cleanable, organisms such as Salmonella, may not be adequately controlled, or eliminated during normal cleaning operations, and thus, may remain as a resident organism.
FDA acknowledges the written response from your firm's Manager, Reynaldo Elizondo, dated February 2, 2010, which addresses observations listed on the FDA 483 issued to your firm. Further, we acknowledge a teleconference on February 4, 2010 between Mr. Elizondo, and members of the Dallas District Compliance Branch. During this teleconference, we informed Mr. Elizondo of FDA's continued concerns with your manufacturing operation.
Upon further contact, Mr. Elizondo indicated your firm was considering sterilizing pecans using a third party vendor. Mr. Elizondo was advised to provide information regarding this change and changes made to your firm's plywood floors, in a written correspondence to the agency. We have not received correspondence from you regarding these two concerns.
You are responsible for ensuring that your processing plant operates in compliance with the Act and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You should take prompt action to correct the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
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 other 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 reply should be directed to Sherrie L. Krolczyk, Compliance Officer, at the address indicated on the letterhead.
Reynaldo R. Rodriguez, Jr.
Dallas District Director