Inspections, Compliance, Enforcement, and Criminal Investigations
Mountain Laurel Log Homes and Land, Inc. dba Kickin Mule 11/14/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Atlanta District Office|
60 8th St., NE
Atlanta, GA 30309
November 14, 2013
Ambrose F. Mezzano, Co-Owner
Jo Marie Mezzano, Co-Owner
Mountain Laurel Log Homes and Land, Inc.
dba Kickin' Mule
1650 Stonecrest Circle
Hiawassee, GA 30546
Dear Mr. and Mrs. Mezzano,
On April 4-10, 2013, the U.S. Food & Drug Administration (FDA) conducted an inspection of your acidified food manufacturing facility located at 1650 Stonecrest Circle, Hiawassee, GA. The inspection revealed serious violations of the 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)). Accordingly, we have determined that your 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. You can find the Act and the Acidified Food regulations through links in FDA's home page at http://www.fda.gov.
As an acidified food 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. These regulations are described in 21 CFR Part 108, Emergency Permit Control, and in 21 CFR Part 114, Acidified Foods. 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 the mandatory requirements of 21 CFR 114.
During our inspection, we observed the following significant violations:
1. As a commercial processor engaged 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). Specifically, your firm has failed to file a scheduled process for all of the acidified foods that your firm manufactures including: Kickin' Mule Olde South Salsa, Kickin' Mule Spicy Chow Chow, and Kickin' Mule Southern Delight. These products were determined to be acidified foods by your process authority as stated in a letter to you dated July 28, 2011.
Additionally, it was determined during the inspection that your firm manufactures other products including wing sauces and barbecue sauces that have not been evaluated by a process authority to determine the status of these foods. Your firm should determine or have determined for you whether any additional products that you manufacture are acidified foods, and comply with the applicable requirements of 21 CFR 108 and 114 including registration and process filing for those products that are determined to be acidified foods.
We acknowledge that you stated at the close out meeting held on April 10, 2013 that you would file your scheduled processes with FDA within one week. We also acknowledge that in your undated response to the FORM FDA 483 that you submitted a copy of a FORM FDA 2541, Food Canning Establishment Registration which you indicate was sent to FDA on April 11, 2013. As of August 21, 2013, this form has not been received by the Center for Food Safety/Office of Food Safety/ Process Evaluation Team nor have they received any scheduled processes for the acidified products manufactured by your firm.
Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic) either electronically or by paper submission. Publications addressing both methods of filing can be found at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/default.htm.
For additional information on the types of products FDA considers to be acidified foods (including thickened water beverages), please refer to the 2010 Draft Acidified Food Guidance Document at the following link: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryinformation/AcidifiedLACF/ucm222618.htm.
2. You failed to manufacture your acidified food products in accordance with the scheduled process as required by 114.80(a)(1). Specifically, review of your production records for "Kickin' Mule Olde South Salsa" reveal cook temperatures of (b)(4) minutes and (b)(4) minutes for the (b)(4) batches manufactured between September 1, 2011 and January 5, 2013. However, the process that was reviewed and approved by the process authority identifies a cook temperature of (b)(4) minutes and (b)(4) minutes. Also, the maximum pH for this product as established in the process reviewed and
approved by the processing authority is (b)(4) however, review of your production records show that there were seven instances where the final pH of the product was measured above (b)(4) for the following batches: 24411/269 (pH 4.39), 26011/277 (pH 4.29), 27211/281 (pH 4.30), 27211/282 (pH 4.27), 27211/283 (pH 4.24), 29111/299 (pH 4.22), 25512/428 (pH 4.22).
We acknowledge that in your undated response to the FORM FDA 483 that you provided a form for recording processing information. We consider the form to be adequate as long as it is completed during the actual period of production and accurately reflects the time, temperature, pH, and container examination performed for each batch. We acknowledge that in your undated response to the FORM FDA 483, you also provided a copy of the "Processing Method Kickin' Mule" procedure. This document correctly identifies the processing temperatures and times for Kickin' Mule Olde South Salsa and Kickin' Mule Spicy Chow Chow as specified in the processes for these products that were approved by the process authority. For the Kickin' Mule Southern Delight product, however, the procedure states the product will be cooked for (b)(4) (b)(4) minutes and (b)(4) minutes. These are not the temperatures/times that are identified in your approved scheduled process for this product which provides for a final cook temperature of (b)(4) minutes. You should take prompt action to ensure that all manufacturing procedures you are using to produce acidified foods result in products that have been manufactured in accordance with the approved scheduled processes.
3. You must maintain processing and production records showing adherence to scheduled processes, including records of pH measurements and other critical factors intended to ensure a safe product, and containing sufficient additional information such as product code, date, container size, and product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production, as required by 21 CFR 114.100(b).
During the inspection the Investigators observed that all processing temperatures/times for all products manufactured since August 2011 were always recorded as (b)(4) minutes and (b)(4) minutes. You informed the Investigator's that you do not take or record actual temperatures at which your acidified products were manufactured. The recording of actual temperatures taken during processing is critical to demonstrate the product has been processed in accordance with the scheduled process approved by the process authority.
We acknowledge the receipt of your undated response to the FORM FDA 483. However, we consider your response for this observation to be inadequate in that it does not specifically state how you plan to correct this deficiency.
4. You must note any departures from scheduled processes having a possible bearing on public health or the safety of the food in a separate file or log that identifies departures from the scheduled process, the action taken to correct them, and the disposition of the product involved as required by 21 CFR 114.100(c). During the inspection the Investigators determined you do not maintain such a log to record departures from the scheduled process or the action taken to correct them, to include the departures described above for Kickin' Mule Olde South Salsa.
We acknowledge the receipt of your undated response to the FORM FDA 483. We consider the response to this item inadequate as it does not specifically state how you will ensure compliance with this regulatory requirement. Specifically, the response does not discuss that a separate file or log will be maintained that will identify any departures from the scheduled process, the action taken to correct them, and the disposition of the product involved.
5. You must maintain records of the examination of raw materials, packaging materials, and finished products to verify compliance with FDA regulations and guidelines or action levels as required by 114.100(a).
We acknowledge the undated response to the FORM FDA 483 that you provided and find that it is partially adequate. The form you provided for recording processing information does include a column to record the final container check. However, to fully comply with this requirement, you must also maintain records of the examination of raw materials and packaging materials, not just finished product.
In addition to the items above, we have the following comment related to the undated response to the FORM FDA 483 you provided:
• In the "Processing Method Kickin' Mule" procedure under item #1 for facility sanitation procedures, it states the tables, sinks, storage bins, walls, and floors are cleaned after every production with very hot water and antibacterial soap. No sanitizing step is stated. In the approved scheduled processes, however, the facility sanitation procedures state the surfaces are not only to be cleaned with hot, soapy water, but they should also be sanitized with a (b)(4)(b)(4) water solution. The procedures you are using must accurately reflect what was submitted and approved by the processing authority for the products you manufacture.
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. Are-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)].
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above noted violations and prevent similar ones. In your response, include documentation of your corrective actions or steps towards long term corrective actions that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. 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 the U.S. Food and Drug Administration, Attn: Janice L. King, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. King at 843-746-2990 or write her at the noted address.
Philip S. Campbell
Acting District Director
Atlanta District Office