Inspections, Compliance, Enforcement, and Criminal Investigations
Sales USA, Inc 11/30/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
November 30, 2012
Kevin Parker, President
Sales USA, Inc.
Dear Mr. Parker:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, located at 801 S. Tyler Road, Gladewater, TX, on August 1 through 3, 2012. The inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation [21, Code of Federal Regulations (CFR) Part 120], and the Current Good Manufacturing Practice regulation for food, [21 CFR Part 110].
In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with 21 CFR Part 120, or otherwise operate in accordance with the requirements of this part, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Food Drug and Cosmetic Act [21 U.S.C. § 342(a)(4)]. Accordingly, your lemon and lime juices are adulterated in that they have been prepared packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, FDA’s labeling and juice HACCP regulations, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant deviations are as follows:
1. You must include in your hazard analysis and HACCP plan control measures that will consistently produce at a minimum, a five-log reduction of the pertinent microorganism for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, as required by 21 CFR 120.24(a). The following critical limits are listed in your HACCP plans for “Lemon Juice”, “Lime Juice”, and “Key Lime Juice”:
- “Temperature of (b)(4) drum (b)(4) degrees or higher” at concentrate receiving,
- “Temperature of concentrate (b)(4) degrees or higher” at concentrate storage,
- “Temperature of concentrate (b)(4) degrees or higher” at concentrate thawing,
- “Concentrate being above (b)(4) degrees or higher for more than (b)(4) consecutive days” at concentrate thawing, and
- “Concentrate being above (b)(4) degrees or higher for more than (b)(4) cumulative days” at concentrate thawing.
However, these critical limits do not provide controls sufficient to ensure a 5-log reduction of the pertinent microorganism, Listeria monocytogenes, in your 100% lemon, lime, and key lime juices.
We acknowledge your firm’s response, dated August 29, 2012, which included a copy of a preliminary analytical result for testing for bacteria, yeast, and mold, as well as a food product evaluation form, and an email from (b)(4). However, your response does not include any proposed control measure that, when applied directly to your juice, will consistently produce at a minimum, a five-log reduction of L. monocytogenes, the pertinent microorganism for your juice. Instead, it advises that “the Listeria screen was negative” and that “(b)(4) states that he cannot see how you can get a 5-log reduction when (b)(4)
Your facility is a final juice processor and packaging site and, consequently, you are required by 21 CFR Part 120, Hazard Analysis and Critical Control Point System (HACCP) to comply with the 5-log reduction process (see 21 CFR 120.24). This section requires you to treat every lot of your 100% juice product with treatments capable of consistently achieving at least a 5-log reduction in the level of the pertinent microorganism in your juice. This requirement is not dependent on the initial numbers of microorganism present in your juice. Applying a 5-log treatment to your juice achieves a tolerable level of risk by ensuring that the process is adequate to destroy any microorganisms of public health significance that may be present in the juice, or to prevent their growth, regardless of their initial numbers.
2. You must adequately monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, compliance with current good manufacturing practice requirements in 21 CFR Part 110 that are appropriate both to the plant and to the food being processed, to comply with 21 CFR 120.6(b). However, your firm did not monitor prevention of cross contamination from insanitary objects to food and food-contact surfaces, as evidenced by the condition of the floor in your production area. Floors in production areas must be kept clean and in good repair. The floor in your production area was uncleanable, with rough and pitted areas in the concrete and deep grooves between the tiles where water and debris could accumulate.
Your firm’s August 29, 2012 response indicates that you are in the process of obtaining a (b)(4) that will (b)(4). This corrective action will be verified during the next inspection.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and FDA’s implementing regulations. You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).
For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these deviations. You should include with your response documentation such as your HACCP plan or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to the Food and Drug Administration, Dallas District Office, Attention: Seri Essary, Compliance Officer, at the above letterhead address. If you have questions regarding any issue in this letter, please contact Ms. Essary at (214)253-5335.
Reynaldo R. Rodriguez, Jr.
Dallas District Director
Thelbert Simpkins, Plant Manager
Sales USA, Inc.
801 S. Tyler Rd.
Gladewater, TX, 75647