- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameJames J. Baerwolf
- Sassy Cow Creamery, LLC
W4192 Bristol Rd.
Columbus, WI 53925
- Issuing Office:
- Division of Human and Animal Food Operations West I
December 4, 2019
Refer to CMS 587954
Dear Mr. Baerwolf:
The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat ice cream manufacturing facility, Sassy Cow Creamery, LLC, located at W4192 Bristol Road, Columbus, Wisconsin, from May 22 to June 4, 2019. This inspection was initiated in response to the recall of Bourbon Honey Pecan Ice Cream in Gluten Free Cookies N Cream ice cream containers that you manufactured. During our inspection of your facility FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations (21 CFR), Part 117. Based on FDA's inspectional findings, FDA has determined that the ice cream manufactured in your facility is 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 it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act, 21 U.S.C. § 331 (uu). You may find the Act and further information about the CGMP & PC rule through links on FDA's home page at http://www.fda.gov.
We received your response dated June 17, 2019, to the issued Form FDA-483, lnspectional Observations. However, your response does not demonstrate that your firm has corrected the violations listed below.
FDA investigators observed the following significant violations of the CGMP & PC rule:
1. You did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (i.e., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(2).
Specifically, your food allergen controls are inadequate at the packaging step to ensure that your finished food is not misbranded under section 403(w) of the Act. Your firm packaged Bourbon Honey Pecan Ice Cream into containers labeled as "Gluten Free Cookies N Cream" on February 22, 2019. This incorrect labeling caused your product to contain an undeclared tree nut allergen which resulted in a Class I Recall.
1. You did not adequately implement preventive controls (i.e., sanitation controls) to provide assurances that any hazards requiring a preventive control (i.e., environmental pathogens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(3).
You have written procedures for sanitation ("Sanitation, Document Reference: 1-12," last revised on January 11, 2019) and sanitation SOPs for equipment (e.g., "Ice cream Freezer - Rinse Procedure" and "Ice Cream Maker - Wash Procedure") that serve as sanitation controls for environmental pathogens such as Listeria monocytogenes (a known or reasonably foreseeable hazard that has resulted in outbreaks of listeriosis from ice cream). You also have "Hygienic Zoning (Barrier Control)" included in "Environmental Monitoring, Document Reference 1-14," last revised June 1, 2018, to "minimize potential environmental pathogen cross-contamination," along with an environmental monitoring program described in the document for verification of the sanitation program. However, you did not adequately implement your sanitation procedures. Specifically:
a. Your sanitation procedure titled "Sanitation, Document Reference: 1-12," last revised on January 11, 2019, states: "Documented cleaning procedures are included in the sanitation program that fully outline the methods used for specific activities and the chemicals used and their concentrations. Concentrations are verified using test kits." You did not document verification of concentrations for the chemicals used during sanitation.
b. Your sanitation procedure titled "Sanitation, Document Reference: 1-12, states: "To verify the effectiveness of sanitation, a (b)(4) of equipment and facility is conducted (b)(4)." No (b)(4) check was observed to be conducted by employees during the inspection on May 22, 23, and 29, 2019, and you are not documenting checks on production or sanitation records.
2. You did not implement written corrective action procedures that must be taken if the presence of an environmental pathogen is detected through environmental monitoring conducted in accordance with 117.165(a)(3), as required by 21 CFR 117.150(a), and did not document all corrective actions, as required by 21 CFR 117.150(d).
Specifically, your written environmental monitoring program titled "Environmental Monitoring Listeria, Document Reference: 1-14 Sub part A.1," dated June 1, 2018, identifies corrective actions to be taken and documented when test results are "out of specification," including "initiate an investigation to determine the source/cause," "[p]erform a full chemical cleaning/sanitation of the area," and "[r]esample (b)(4) days." From May 21, 2018, through December 24, 2018, you did not perform re-sampling on (b)(4) days and did not document written corrective actions for any of the swabbed areas after out-of-specification Listeria spp. results were received.
3. You did not adequately verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing a hazard with environmental monitoring, as required by 21 CFR 117.165(a).
Specifically, your written environmental monitoring program titled "Environmental Monitoring Listeria, Document Reference: 1-14 Sub part A.1," provides that swabbing for Listeria spp. will be conducted (b)(4). You did not conduct environmental swabbing at the frequency required by your environmental monitoring program. As reflected in the absence of test results for these time periods, you did not conduct any environmental swabbing for Listeria spp. in the months of August 2018, October 2018, January 2019, and March 2019.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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 non-compliance 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 domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Please respond to this office in writing within 15 working days from your receipt of this letter. Your response should identify the procedures you have taken or will take to completely correct the current violations and prevent similar ones. In your response please include the timeframe in which the corrections will be completed and provide documentation that will effectively assist us in evaluating whether the corrections have been made and their adequacy. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the correction(s). If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Boun M. Xiong, Compliance Officer, at the address listed in the heading of this letter. If you have questions regarding any issue in this letter, please contact Mr. Xiong at (414) 326-3976.
Michael Dutcher, DVM
Director, West Divison 1
Office of Human and Animal Food Operations