- G. Wolf Enterprises, Inc.
- Issuing Office:
- Seattle District Office
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
In reply refer to Warning Letter SEA 14-18
George O. Wolf, President and Owner
14811 Moonlight Drive
Dear Mr. Wolf:
We received your written responses on May 30, 2014, and June 13, 2014, to the Form FDA 483, Inspectional Observations, issued to your firm on May 14, 2014, and your corrective actions are addressed under each violation below.
Acidified Foods Violations
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.
1. 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 a new product, provide FDA information as to 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, as required by 21 CFR 108.25(c)(2).
Specifically, your firm has failed to file a scheduled process with FDA for the following seventeen acidified foods that your firm manufactures which include: Original pickled cucumbers in 24 oz. glass jars; Double Garlic pickled cucumbers in 24 oz. glass jars; Hot Spicy pickled cucumbers in 24 oz. glass jars; Old Fashioned Spicy pickled cucumbers in 24 oz. glass jars; spicy dill pickles in 32 oz. glass jars; spicy dill pickles in 64 oz. glass jars; (b)(4) Sliced Garlic (b)(4) in 10 oz. glass jars; (b)(4) Sliced Garlic (b)(4) in 10 oz. glass jars; (b)(4) Sliced Garlic (b)(4) in 10 oz. glass jars; (b)(4) Sliced Garlic (b)(4) in 6 oz. glass jars; (b)(4) Sliced Garlic (b)(4) in 6 oz. glass jars; (b)(4) Sliced Garlic (b)(4) in 6 oz. glass jars; (b)(4) Sliced Garlic (b)(4) in 10 oz. glass jars; (b)(4) spice condiment in 9 oz. glass jars; (b)(4) in 10 oz. glass jars; pickled asparagus in 12 oz. glass jars; and cilantro chutney in 12 oz. glass jars.
Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Process Filing for all Processing Methods Except Low Acid Aseptic). More information on filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007437.htm.
Your written response received May 26, 2014, is inadequate as no documentation was provided showing scheduled processes were filed with FDA.
Your written response received June 13, 2014, included copies of two new process filings for the following two products: (b)(4) Sliced Garlic (b)(4) (SID (b)(4)) and (b)(4) spice condiment (SID (b)(4)). We acknowledge that FDA received these scheduled processes June 17, 2014; however, they were returned to you on July 17, 2014, and need to be resubmitted with the appropriate process information in order to be in compliance with 21 CFR 108.25(c)(2). In addition, your response included previously submitted process filings which FDA had returned for the following two products: Garlic, Sliced in Oil (SID (b)(4)) and (b)(4) Sliced Garlic (b)(4) (SID (b)(4)). These process filings must also be resubmitted to FDA if you wish to manufacture these acidified food products.
Your written response received on May 26, 2014, is inadequate as it did not include documentation of the corrective actions taken to address the affected product, process and preventing its reoccurrence. Additionally, your written response did not include documentation completed by the operator performing the visual inspection showing the results of non-destructive or destructive tests.
3. Your firm has failed to manufacture your acidified food products in accordance with the scheduled process, as required by 21 CFR 114.80(a)(1). Specifically, the November 4, 2011, process letter for your (b)(4) product provided by a process authority identified the product as an acidified food and listed a minimum core temperature of (b)(4)°F. However, our investigators’ review of your production records from February 26, 2014, revealed a core temperature of 175.5 °F for one batch of (b)(4) produced on that day.
Your written response received on May 26, 2014, is inadequate as you state that your (b)(4) product is a formulated acid food although the process authority letter, supplied by your customer, identified this product as an acidified food. Corrective actions should be taken to address the process deviation in accordance with 21 CFR 114.89, and this scheduled process must be filed with FDA in order to comply with 21 CFR 108.25(c)(2). In addition, your firm’s scheduled processes must be established by a qualified person with expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods, as required by 21 CFR 114.83. Any products that are determined to be low-acid canned foods or acidified foods must have scheduled processes on file with FDA.
4. Your firm failed to record the procedures used in the evaluation of process deviations and results of process deviation evaluations, as required by 21 CFR 114.89. Specifically, in addition to not having a scheduled process filed with FDA, review of your processing records for your (b)(4) Sliced Garlic (b)(4) product produced on October 29, 2013, revealed a finished product equilibrium pH of 4.7, exceeding the maximum finished equilibrium pH of 4.6 as required in the regulation for acidified foods (21 CFR 114). Your firm reprocessed the affected product on November 6, 2013; however, you did not maintain records showing the affected product was held under refrigeration prior to reprocessing and did not maintain records showing that the affected product was evaluated by a process authority. An invoice dated November 12, 2013, showed this (b)(4) Sliced Garlic (b)(4) product was released for shipment.
Your written response received on May 26, 2014, is inadequate as you stated the situation was resolved and a determination as to food safety was made, however, you did not provide documentation of the corrective actions taken to address the affected product, process and preventing its reoccurrence. Your May 26, 2014, response also did not include documentation showing the affected product was held under refrigeration prior to reprocessing and did not include records showing the affected product was evaluated by a process authority.
As a seafood processor, you are required to comply with the Act and the federal regulations relating to the processing of seafood products and current good manufacturing practices. These regulations are described in 21 CFR Part 123, Fish and Fishery Products, and 21 CFR Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.
5. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, as required by 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for (b)(4) spice condiment packed in 9.0 ounce glass jars, which contains shrimp, to control the food safety hazard of undeclared allergens.
As a food processor, you are required to comply with the Act and the federal regulations relating to current good manufacturing practices.
These regulations are described in 21 CFR Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.
b. Apparent mold and dust on a pipe directly above an uncovered fill funnel containing exposed peanut sauce and uncovered jars of peanut sauce at the entry of the exhaust steam tunnel.
c. White containers, used to hold washed cucumbers, stored directly on the wet floor of the production area between uses.
d. Cardboard liners in direct contact with unprocessed cucumbers stored within open jars and wood flats used to store open jars of cucumbers, both of which are constructed of materials which cannot be adequately cleaned and properly maintained.
e. Pooled liquid on the floors of the processing area, which splashed onto wood flats storing processed jars of cucumbers and peanut sauce.
f. Residue on the inner surfaces of the (b)(4) steam cooker, used to process cucumbers and peanut sauce.
Your written response received on May 26, 2014, is inadequate as it does not promise corrective actions related to items 6c, 6d and 6e. The corrections you have made related to items 6a, 6b and 6f will be verified during the subsequent inspection.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the acidified foods regulation (21 CFR Parts 108 and 114), the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110), and (b)(3)(A). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4), the acidified foods and seafood HACCP regulations. We may also take further action to enjoin your firm from operating in violation of Section 415 of the Act (21 U.S.C. § 350d) and 21 CFR Part 1, Subpart H. 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)). 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 respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or 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 written response should be sent to the following address: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of LCDR Cynthia White, Compliance Officer. Should you have any questions concerning this letter, you can contact LCDR White at 425-302-0422.
Washington State Department of Agriculture