May 6, 2019

Warning Letter 575444


Luconda M. Dager, President
Velvet Ice Cream Company, Inc.
11324 Mount Vernon Road
Utica, OH 43080

Dear Ms. Dager:

The United States Food & Drug Administration (FDA) inspected your Ready-to-Eat (RTE) ice cream manufacturing facility, located at 11324 Mount Vernon Road, Utica, Ohio from January 23 to February 14, 2019. 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, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, including the same strain found during FDA’s 2018 inspection. Based on FDA’s inspectional findings and the analytical results for the environmental samples, we 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 was prepared, packed or held under insanitary conditions 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 in FDA’s home page at

FDA’s inspection resulted in issuance of an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

Hazard Analysis and Risk-Based Preventive Controls (Subpart C):

You are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control 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 (21 U.S.C. §§ 342 or 343(w)) to comply with 21 CFR § 117.135(a)(1). In your food safety plan, you identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes, as required by 21 CFR §§ 117.135(a)(1) and (c)(3).

Nine environmental swabs collected by FDA during our most recent inspection were positive for L. monocytogenes. Furthermore, environmental swabs collected during our 2018 inspection revealed L. monocytogenes in nine swabs within your facility and environmental swabs collected during our 2017 inspection revealed L. monocytogenes in three swabs within your facility. Whole genome sequencing (WGS) of isolates detected in the FDA environmental samples identified twenty-one isolates representing six different strains of L. monocytogenes. The same strain of L. monocytogenes was identified in seven isolates from environmental samples collected during the 2019 inspection and eight isolates collected during the 2018 inspection. We advised you of those WGS results via a conference call on February 27, 2019. The presence of the same strain of L. monocytogenes over multiple years indicates that there has been a resident pathogen or harborage site in your facility since 2018. Additionally, that strain of L. monocytogenes was genetically identical to one clinical isolate collected in 2018, which indicates this strain has the capability of causing human illness.

These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in your facility. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.

Furthermore, from (b)(4) through (b)(4), you performed (b)(4) environmental monitoring for Listeria spp. During the referenced time period, your facility found Listeriaspp. in your environment seven times on surfaces adjacent to Zone 1 locations and other non-food contact surface locations within your processing environment including areas within your RTE room. Review of your records finds that your written corrective action procedures were followed each time a positive swab was found in your facility; however, these repeated findings of Listeria in your environment are further evidence that additional measures may be needed in your facility to address Listeria.

We acknowledge you have committed to performing corrective actions in written responses which we received on February 7, February 27, March 16, and April 24, 2019. In your written responses, you indicate that you have conducted a root cause analysis to identify the source of our findings, cleaned and sanitized your production environment, conducted environmental swabbing to verify the effectiveness of your cleaning, and completed other activities to address the problems. We recommend that you continue to identify potential harborage sites and source(s) of the organism in your processing environment and implement the necessary methods and controls to ensure the foodborne pathogen does not contaminate your RTE food products. We will verify the effectiveness of your corrective actions during our next inspection.

Current Good Manufacturing Practice (Subpart B):

1. You did not clean your non-food contact surfaces in a manner and as frequently as necessary to protect against contamination, as required by 21 CFR 117.35(e). Specifically, on January 30, 2019, our investigators observed an employee using a high-pressure hose to spray the floor with water while performing sanitation operations. They observed overspray from the floor onto equipment reported as having been cleaned and from the floor onto unopened buckets of ingredients that were going to be used to produce ice cream the next day.

Your corrective action indicates that you will lower the water pressure and retrain your employees on the use of water and clean up procedures. We will verify the adequacy of this corrective action during our next inspection.

2. Your plant was not constructed and designed to facilitate maintenance and sanitary operations, as required by 21 CFR 117.20(b). Specifically, the design of the production floor does not allow for the proper drainage of water. Water used in the cleaning of equipment pools in various locations throughout the production area of your facility, which can provide harborage areas for pathogenic bacteria such as Listeria.

Your corrective actions indicate that you have re-sloped your floor to address the observations of pooling water. We will verify the adequacy of this corrective action during our next inspection.

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.

Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-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 re-inspection and assessing and collecting the re-inspection fees, [21 USC 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.

Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections.

If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Please send your reply to the Food and Drug Administration, Attention: Stephen J. Rabe, Compliance Officer, 6751 Steger Drive, Cincinnati, OH. If you have questions regarding any issues in this letter, please contact Mr. Rabe at 513-679-2700, extension 2163 or


Steven B. Barber
Director, Division 5
Office of Human and Animal Foods Operations East