Inspections, Compliance, Enforcement, and Criminal Investigations
Old Fashioned Foods, Inc. 8/16/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
August 16, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 12 – 40
Bernard P. Youso
Old Fashioned Foods, Inc.
650 Furnace Street
Mayville, Wisconsin 53050
Dear Mr. Youso:
The Food and Drug Administration (FDA) conducted an inspection of your low-acid and acidified food manufacturing facility located at 331 South Main Street Mayville, Wisconsin, and your warehouse facility located at 650 Furnace Street, also in Mayville, Wisconsin, on April 10-11, 13, 17, 20, 23, 25 and May 4, 2012. The inspection found that your firm manufactures a wide variety of low-acid shelf-stable food items including processed cheese food items, cream cheese, salad dressings, mayonnaise, jellies, salsas and pet treat products. Most of your firm’s products are hot-filled and packaged in a variety of containers including plastic squeeze bottles, foil packs, aerosolized cans, plastic tubs, and glass jars for both humans and pets. The inspection found your firm has one retorted product, Salsa Con Queso, and acidified bean dip products. The inspection determined that you have significant deviations from the Low-Acid Canned Foods regulations, Title 21, Code of Federal Regulations, Part 113 (21 CFR 113), and that you have significant deviations from the Acidified Foods regulations, 21 CFR 114.
As a manufacturer of acidified foods and low-acid canned food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified food and low-acid canned food products. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, and 21 CFR 114, Acidified Foods. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for acidified foods and low-acid canned foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35 and 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR 113 and 114.
In addition, based upon certain criteria in 21 CFR 113 and 114, acidified foods may be adulterated within the meaning of section 402(a)(4), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the acidified and low-acid food regulations through links on FDA’s Internet home page at www.fda.gov.
Observations with regard to your firm’s deviations from the Low-Acid Canned Foods regulations, 21 CFR 108 and 21 CFR 113, include:
1. As a commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers, you must, not later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled processes. This information must include the processing method, type of retort or other thermal processing equipment employed, minimal initial temperatures, times and temperatures of processing, sterilization value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process for each low-acid food in each container size, to comply with 21 CFR 108.35(c)(2). However, your firm has not filed scheduled processes with FDA for all of your low-acid food products including varieties of cheese melt products, cheese spread products, cheese stick products, and pet treat products. This is a repeat observation from your previous inspection.
Scheduled process information for acidified and low-acid foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low-Acid Aseptic). More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods” available at: http://www.fda.gov/Food/Foodsafety
2. Your firm failed to established a scheduled process by a qualified person with expert knowledge acquired through appropriate training and experience of thermal processing requirements for low-acid foods in hermetically sealed containers and having adequate facilities for making such determinations as required by 21 CFR 113.83. Your firm manufactures and distributes:
- Cheese sticks that are high moisture, low-acid food in a hermetically sealed container that is considered shelf stable. These products have not been evaluated by a process authority.
- Several pet food products in aerosol cans, in a variety of flavors that are high moisture, low-acid shelf stable foods. These products have not been evaluated by a process authority.
3. Your firm failed to file with FDA changes in previously filed scheduled processes, where processing parameters were higher or longer, when the processes became regularly scheduled as required by 21 CFR 108.35(c)(3)(ii). Specifically, the current scheduled process filed with the FDA for the Salsa Con Queso product in glass jars processed in the (b)(4) retort lists the critical factors for minimum cook time at (b)(4) minutes and minimum cook temperature of (b)(4)°F with initial temperature (b)(4)°F. This process has been updated in a study from (b)(4) conducted March 2012 with updates to the critical factors including minimum cook time (b)(4) minutes, minimum cook temperature (b)(4)°F and initial temperature (b)(4)°F. These updates are higher than what is currently on file with FDA. You have not updated your filing with FDA.
4. Your firm failed to process each low-acid canned food in conformity with at least the scheduled process filed with FDA, as required by 21 CFR 108.35(c)(3)(i). Specifically,
- Your scheduled process on file with FDA for your processed cream cheese lists the critical factor of a minimum (b)(4). No (b)(4) testing is performed.
- Your scheduled process on file with FDA for your processed cream cheese product lists the critical factor of (b)(4). A review of your laboratory analysis sheet shows a (b)(4) range from (b)(4). All batches and lots of the cream cheese products reviewed were shipped to customers without being evaluated by your process authority.
- Your scheduled process on file for cheese topping product references a study conducted by your process authority that states the (b)(4) is a critical factor and must be at a minimum of (b)(4) in the finished product. No (b)(4) testing is performed.
5. Your firm’s management, or qualified representative, failed to review, sign and date processing and production records for completeness and to ensure that the product received the scheduled process as required by 21 CFR 113.100(b). Specifically, a variety of processing records from September 2011 thru April 2012 were reviewed. There was no signature, initials, or date by a reviewing official from the firm.
Observations regarding deviations from the Acidified Foods regulations, 21 CFR 114, include:
6. As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of any new product, provide the Food and Drug Administration information on the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels and source and date of the establishment of the process, for each acidified food in each container size to comply with 21 CFR 108.25(c)(2). Your firm has not filed a scheduled process with FDA for your shelf-stable acidified Jalapeno Bean Dip.
7. Your firm failed to established a scheduled process by a qualified person with expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods as required by 21 CFR 114.83. This is a repeat observation from your previous inspection. A current example is as follows: Your firm manufactures and distributes Jalapeno Bean Dip and Zesty Bean Dip that is intended to be shelf-stable that is packaged in a hermetically sealed container as an acidified food. A qualified process authority has not evaluated these Bean Dips to establish critical factors and processing parameters to ensure they meet safety requirements.
8. Your firm failed to ensure acidified foods are manufactured, processed, and packaged so that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods as required by 21 CFR 114.80(a)(1). During the course of our inspection a sample of your Jalapeno Bean Dip was collected and analyzed for pH and Water Activity. Out of a total of 48 tests, 34 analyses were found with a pH at or above 4.6. Additionally, in a lot of your acidified Jalapeno Bean Dip your QA laboratory analysis found the pH to be (b)(4).
9. Your firm failed to fully reprocess, thermally process as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance, a portion of food which had an equilibrium pH of the finished product higher than 4.6 as required by 21 CFR 114.89. Specifically, in a lot of your acidified Jalapeno Bean Dip your QA laboratory analysis found the pH to be (b)(4). This lot was not set aside for further evaluation, but was shipped to customers.
10. Your firm failed to mark each container with the required identification with a code specifying the establishment where the product was packed, product contained therein, and the packing period, as required by 21 CFR 114.80(b). Specifically, the code on your firm’s Zesty Bean Dip does not identify the establishment where it was packed or the product inside.
This letter is not intended to be an all-inclusive list of deficiencies in your manufacturing facility and your product labels. It is your responsibility to ensure that all of your products comply with the Act, the low-acid canned food regulations (21 CFR 108, 113 and 114), the Current Good Manufacturing Practice regulation (21 CFR 110), and other applicable regulations. You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice, such as seizure or injunction.
We have received your responses dated May 11, 23, and 29, 2012, to the form FDA-483, Inspectional Observations. However, your responses are inadequate in that you have not provided any documentation of your corrective actions in support of your promised corrections. You have not provided evidence that you will discontinue manufacture of products until your processes are evaluated by a competent process authority, or that you have filed these processes with FDA, that you are monitoring your operations in accordance with this filing, and that, if deviations are noted, you will take the appropriate actions. As a result of your previous inspectional findings and your continued non-compliance with FDA regulations we find it necessary to put you on notice that continued non-compliance with FDA regulations may result in further regulatory action including seizure and/or injunction.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
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 non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your response should be sent to the Food and Drug Administration, Attention: Demetria L. Lueneburg, Compliance Officer, at the address listed on this letterhead. If you have any questions with regard to this letter, you may contact Ms. Lueneburg at (612) 758-7210.
Michael Dutcher, DVM