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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Flavour Makers Pty Ltd 9/12/13


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
5100 Paint Branch Pkwy
College Park, MD 20740 


September 12, 2013
VIA EXPRESS DELIVERY                                                                                 
Mr. Alex Severino
Quality Assurance Manager
Flavour Makers Pty., Ltd.
Dry Blending Facility
91-97 Woodlands Drive
Braeside, Victoria, 3195, Australia
Reference No. 396095
Dear Mr. Severino:
On January 8 and 9, 2013, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of your acidified sauces processing facility, Flavour Makers Pty., Ltd., located at 2-4 Henley Court, Moorabbin, Victoria, 3189, Australia. During the inspection, we found that you have significant deviations from the requirements for acidified foods in Title 21, Code of Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR Part 108); and Part 114, Acidified Foods (21 CFR 114). These deviations cause the acidified foods processed at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] because these foods have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
The following violations were observed during the inspection:
  • A commercial processor engaged in processing acidified foods in any registered establishment shall process each food in conformity with at least the scheduled processes filed under 21 CFR 108.25(c)(2) in order to comply with 21 CFR 108.25(c)(3)(i). However, your firm failed to process your acidified foods in conformity with at least the scheduled process filed under 21 CFR 108.25(c)(2). Specifically:
o    Your firm’s filed scheduled process for Korma Simmer Sauce, (b)(4), shows a (b)(4). However, as observed on your production records, your Korma Simmer Sauce was manufactured at a (b)(4). In addition, the manufacturing temperature for your Korma Simmer Sauce observed during the inspection ranged from (b)(4).
The process that you deliver to the product must be at least equal to the process recommended by your Process Authority (PA), which is the process your firm files with the FDA. The process can be in excess of what is recommended by the PA, but it cannot be less than the critical factors filed in your scheduled process based on the parameters your PA recommended.
We acknowledge receiving a revised scheduled process filing for your Korma Simmer Sauce, which reflects the current manufacturing process parameters; however, that process filing was returned on April 23, 2013, based on FDA’s determination that the process source is invalid. Therefore, we recommend that you re-submit this scheduled process with a valid process source letter that includes the appropriate process parameters.
o    Your firm’s filed scheduled processes state you will manufacture your acidified food products with a thermal processing method of “(b)(4).” However, in practice, your firm does not follow this processing method.
Your firm’s manufacturing operation for each of your acidified sauces is to cook the product in a (b)(4) according to its formulation. After the product is cooked, the product is moved via pipes to a closed (b)(4), which is indirectly heated to maintain the product at the same temperature as in the cooking step. From the (b)(4), the product goes into a (b)(4) the product pouches. (b)(4) pouch is filled and sealed, the pouch is cooled.
Because you filed these processes as “(b)(4)” processes, you must adhere to the critical factors of “(b)(4).” This means that the temperature of the product at the (b)(4) must be at least the “(b)(4)” temperature as listed in the scheduled processes and must be held in the pouches for the identified “(b)(4).” However, the temperature of the product in the pouch is not held at the scheduled (b)(4) for the scheduled time prior to cooling, nor is it heated in the pouch to the scheduled temperature after (b)(4) for the scheduled time prior to cooling.
This letter may not list all your deviations from the requirements of the Act and regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Acidified Food regulation and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation, such as a copy of any revised procedures; at least five (5) days of processing records to demonstrate that you have implemented the revised procedures; and any other useful information that would assist us in evaluating your corrections. If you wish to change your process, you need to amend your process filing to reflect any changes and provide a process source. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your acidified sauce products under Section 801(a) of the Act [21 U.S.C. § 381(a)], including placing them on detention without physical examination (DWPE).  FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the acidified food regulation is Import Alert #99-04. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/ialist.html
Additionally, 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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign 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 reinspection-related costs. You should consider providing your U.S. Agent with a copy of this letter.
Please send your reply to the U.S. Food and Drug Administration, Attention: Stuart A. Feldman, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Mr. Feldman by phone at (240) 402-3006 or by email at stuart.feldman@fda.hhs.gov.
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
   and Applied Nutrition