February 3, 2017
VIA UPS OVERNIGHT DELIVERY
Richard Pierce and Marlene Pierce, Co-owners
MBDR Foods, LLC
1044 Schoolview Dr. Marshfield, MO 65706
Reference CMS Case # 516352
Dear Mr. Pierce and Ms. Pierce:
Between December 13, 2016-January 17, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1044 Schoolview Dr., Marshfield, MO 65706. The inspection revealed that your firm manufactures acidified food products. The inspection also revealed that you have serious deviations from regulations for acidified foods (Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 114)) and the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (21 CFR Part 110). Accordingly, we have determined that your firm’s acidified food products are 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)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
As an acidified foods processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and mandatory requirements of 21 CFR Part 114. You can find the Act and the Acidified Food and Food Labeling regulations through links in FDA’s home page at http://www.fda.gov.
During our inspection, our investigators observed the following significant violations:
1. As a commercial processor in the thermal processing of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). However, our inspection revealed you failed to file a scheduled process with FDA for your firm’s Hopsing Stir Fry Sauce, Hopsing Sweet and Sour Sauce, and Hopsing General Tso's Sauce. You have been manufacturing this product using your firm’s Hopsing Stir Fry Sauce, Hopsing Sweet and Sour Sauce, and Hopsing General Tso's Sauce formulation and process, which has been determined to be an acidified food product by your process authority.
In addition, a commercial processor of acidified foods is required, not later than 10 days after first engaging in the manufacture, processing, and packaging of acidified foods in any state, as defined in section 201(a)(1) of the Act, to register and file a Form FDA 2541 (Food Canning Establishment Registration) with the FDA, as required by 21 CFR 108.25(c)(1). However, our inspection indicates that your firm processes acidified food products without being registered as a processor of acidified foods.
Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). More information on registration and filing can be found in the publication “Guidance for Industry: Submitting Form FDA 2541 (Food Canning
Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format” available at: 76.htmhttp://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm3093
2. Your firm failed to process each acidified food in conformity with at least the scheduled process, as required by 21 CFR 108.25(c)(3)(i). Specifically, on December 13, 2016, our investigators observed you manufacture 12oz Hopsing Stir Fry Sauce Best By May 23 2019. During this process, you did not invert your filled containers for (b)(4) as required by your process authority letter dated July 17, 2016.
3. You must maintain processing records showing adherence to the scheduled process, including records of critical factors, as required by 21 CFR 114.100(b). Specifically, production records of products manufactured by your firm from August 28, 2016 to December 4, 2016 do not document finished equilibrium pH, process time and temperature, fill temperature, or inverted container hold time of finished product as required by your scheduled process. During this period you manufactured (b)(4) batches of acidified products including, but not limited to:
- Hopsing Stir Fry Sauce manufactured on November 30, 2016 and December 1, 2016,
- Hopsing General Tso's Sauce manufactured on November 28, 2016, and
- Hopsing Sweet and Sour Sauce manufactured on November 29, 2016 and December 4, 2016.
4. You must mark each container with an identifying code specifying the establishment where the product was packed and the product contained therein, as required by 21 CFR 114.80(b). Specifically, on December 13, 2016, our investigators observed lot codes on finished acidified products manufactured by your firm that did not include the place of manufacturing or product manufactured. This included Hopsing Stir Fry Sauce Best By May 23 2019.
5. Your firm failed to have personnel involved in acidification, pH control, heat treatment, or critical factors under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner, as required by 21 CFR 108.25(f). Specifically, our inspection revealed no one at your firm has attended a Better Process school and you could not provide any documentation that a qualified individual had supervision over your firm's acidified foods production.
6. Your firm failed to maintain gloves, used in food handling of finished food products, in an intact, clean, and in sanitary condition, as required by 21 CFR 110.10(b)(5). Specifically, our investigators observed an employee touch non-food contact surfaces with a gloved hand and then touch food contact surfaces. The observation includes, but is not limited to:
- On 12/13/2016, an employee while gathering, measuring, adding, and mixing ingredients into an open top five (5) gallon container had a tear on the glove worn on his right hand. The tear extended from the palm to the backside on the hand across the area between the thumb and fore finger. At the time, the employee was in production of "Hopsing Oriental Stir Fry Sauce" in 12 oz jars and "Hopsing General TSO's General Chicken Sauce in 12 oz. jars.
- On 12/13/2016, an employee, while capping the filled product, was observed picking up a lid which had fallen to the floor and placing it in a sink. The employee did not wash or sanitize his gloves before returning to capping the filled jars of product. At the time, the employee was in production of "Hopsing Oriental Stir Fry Sauce" in 12 oz jars and "Hopsing General TSO's General Chicken Sauce in 12 oz. glass jars.
- On 12/19/2016, an employee, while in process of mixing product was observed answering a cell phone and returning to production without washing or sanitizing their hands. At the time, the employee was in production of "Hopsing Sweet & Sour Sauce Dipping & Glazing Sauce" in 12 oz. glass jars.
- On 12/19/2016, an employee, while in production was observed gathering trash and empty packaging material and placing them in an empty sugar sack and taking it outside the production area to the trash receptacle. The employee did not wash their hands before proceeding with production of the acidified product. At the time, the employee was engaged in the production of "Hopsing Sweet & Sour Dipping and glazing Sauce" in 12 oz. glass jars and one (1) gallon plastic containers.
Food Facility Registration
The Food and Drug Administration has determined that your facility (b)(3)(A). During the inspection of your facility, you were advised of this requirement. (b)(3)(A)
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
U.S. Food and Drug Administration, (b)(3)(A)
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective action may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
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.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Your written response should be sent to Jessica E. Hensley, Compliance Officer, U.S. Food and Drug Administration at the above address. If you have questions about this letter, please contact CO Hensley at Jessica.firstname.lastname@example.org or 913-495-5183.
Cheryl A. Bigham
Kansas City District Office