Inspections, Compliance, Enforcement, and Criminal Investigations

5 Spoke Creamery, LLC 10/19/18

  

Department of Health and Human Services logo

 
 
U.S. Food and Drug Administration
Office of Human and Animal Food Operations East
Division 1
www.fda.gov

 

WARNING LETTER
CMS # 559898

VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

October 19 2018

Mr. Alan J. Glustoff, Co-Owner
Ms. Barbara K. Glustoff, Co-Owner
5 Spoke Creamery, LLC
1089 Pulaski Hwy
Goshen, NY 10924-6116

Dear Mr. and Ms. Glustoff:

The United States Food and Drug Administration (FDA) inspected your Ready-to-Eat (RTE), aged raw milk cheese manufacturing facility located at 1089 Pulaski Hwy, Goshen, NY, 10924 from April 10 through May 24, 2018.  During our inspection, FDA collected environmental samples from various areas in your facility, including areas that are near food during processing operations and your food contact surfaces.  FDA laboratory analyses of the environmental samples (i.e., swabs) identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. At the conclusion of the inspection, the investigator issued your facility an FDA Form 483, Inspectional Observations, which documented insanitary conditions in your facility at the time of the inspection. Based on FDA’s analytical results for the environmental swabs coupled with observations made by our investigator during that inspection, we have determined that during that inspection you were processing your RTE, aged raw milk cheese under conditions that cause your cheese products to be 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 were prepared, packed, or held under insanitary conditions whereby your cheese products may have been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.

Additionally, based on a subsequent review of your website at www.5spokecreamery.com, we have identified serious violations of Section 201(g)(1)(B) of the Act [21 U.S.C. §321(g)(1)(B)] and applicable regulations.  The claims made on your website establish that your “5 Spoke Creamery Grass Fed Raw Cow’s Milk Cheese” products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. 

We acknowledge your firm’s response to FDA Form 483 dated June 7, 2018, which included a description of corrective actions taken by your firm. The adequacy of your firm’s implementation of those actions and your firm’s ability to effectively control the presence of the pathogen, L. monocytogenes in your facility will be assessed during our next inspection. It is important to implement an effective strategy for environmental control of L. monocytogenes within your processing and packing environment.  Although FDA recognizes that effective controls against this organism can be challenging, it is your responsibility to effectively address this challenge to ensure the safety of your products. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.

Furthermore, in August 2018, New York State Department of Agriculture and Markets (NYSDAM) initiated an inspection and collected finished product samples from your facility. Review of the results of NYSDAM’s inspectional reports further confirms our concerns about the ability of your firm to make and sustain corrective actions. These concerns will be further explained in this letter.

Pathogen Findings

FDA laboratory analysis of the environmental samples INV1041983 and INV1041984 collected at your facility on April 10 – 11, 2018, determined that four (4) of one hundred thirty-eight (138) environmental swabs were positive for L. monocytogenes. One of the positive swabs was taken from a wooden aging board on which your Porter cheese was aging directly on the board.

We conducted Whole Genome Sequencing (WGS) testing and comparative analysis and advised you about our results via a conference call on May 8, 2018. We conducted WGS analysis on the following:

• three (3) L. monocytogenes isolates obtained from the FDA environmental sample 1041984;
• one (1) L. monocytogenes isolate obtained from the FDA environmental sample 1041983;
• one (1) finished product sample of Herbal Jack cheddar cheese manufactured by your facility on May 26, 2017, sampled by NYSDAM on October 30, 2017; and
• one (1) finished product sample of Redmond Cheese manufactured by your facility on April 2, 2018, sampled by NYSDAM on August 13, 2018.

Prior to the issuance of this Warning Letter, the Agency updated the comparative analysis.  The WGS phylogenetic analysis had found that these six (6) isolates contain four (4) different strains of L. monocytogenes. Specifically of significance, the same strain was found in two (2) isolates from FDA Sample 1041984, the one (1) finished product sample of Herbal Jack cheddar cheese manufactured by your facility on May 26, 2017, and two (2) clinical isolates collected in 2018.

These current environmental swab samples in addition to the finished product samples collected by NYSDAM indicate that your facility is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate and minimize exposure to food and food contact surfaces during production.  This evidence demonstrates that the same strain of L. monocytogenes has maintained a presence within your production facility since May 2017. The reoccurring presence of an identical strain of L. monocytogenes in your products and manufacturing environment indicates that a resident strain or niche harborage site is present in your facility. These findings also demonstrate that your sanitation procedures are inadequate to control this pathogenic organism 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. 

We have received your June 7, 2018, response outlining the corrective actions you have taken in response to the L. monocytogenes environmental sample findings. These corrective actions include cleaning and sanitizing your processing environment, conducting environmental sampling, and conducting finished product testing for L. monocytogenes. At this time, we do not have enough information and consequently cannot verify the adequacy of the methods and controls you have implemented to identify the potential harborage sites for L. monocytogenes in your processing environment or that the methods and controls effectively prevent L. monocytogenes from contaminating finished products you may manufacture in the future. We will verify the adequacy of your corrective actions during any future inspection.

We encourage you to review FDA’s draft guidance for industry titled, “Control of Listeria monocytogenes in Ready-To-Eat Foods” for assistance in developing your Listeria control plan. The draft guidance can be found at:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm073110.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery  FDA intends to issue a final version of this guidance in the future.

Current Good Manufacturing Practice (CGMP) Violations
 
Additionally, FDA investigators observed the following significant violations of the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110):
 

1. Failure of equipment and utensils to be designed and of such material and workmanship as to be adequately cleanable, and failure to properly maintain equipment and utensils, as required by 21 CFR 110.40(a). Specifically, FDA investigators observed numerous wooden boards you use for aging raw milk cheese products in the cheese aging cave are of a design that does not allow them to be appropriately cleaned and sanitized.  The aging boards were observed to have uneven surfaces, to be rough cut, and to have knots, frays, and splinters. Moisture buildup was observed on some of the boards.  Porter, Harvest Moon and Tumbleweed aged RTE raw milk cheese products were observed to be aging on these wood boards.

Your June 7, 2018, response outlines the corrective actions you plan to take in response to this violation which includes purchasing new cheese boards, hiring a consultant, conducting cleaning and sanitizing operations, swabbing of areas that were previously found positive for L. monocytogenes and destroying (b) (4) of Porter cheese (lot (b) (4) ). However, your response does not indicate how you will ensure the maintenance of the cheese boards.

2. Failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(1).  Specifically, on 4/30/2018, FDA investigators observed orange apparent cheese-like particles on the floor immediately below the north end of the cheese vat in the manufacturing room, as well as on a few stainless-steel form holders stored on the cheese press table. This residue was observed after post-production cleaning performed on 4/25/2018 and pre-production sanitation procedures for the current manufacturing day were performed. Investigators also observed apparent cheese-like particles on the blades of the cheddar mill in the manufacturing room. The cheese mill appeared to be last used on 4/2/2018.

Your June 7, 2018, response outlines the corrective actions you have taken in response to this violation to include cleaning and sanitizing the equipment and your plan to conduct a visual inspection of the facility and equipment after cleaning and sanitizing operations have been performed.   However, your response does not provide information regarding how the corrections you have taken will be sustained and/or implemented to prevent recurrence.

Additionally, we note that NYSDAM’s Division of Milk Control & Dairy Services recently conducted an inspection at your facility and according to their “Sanitary Plant Inspection-DMC 1503” form dated August 16, 2018, sanitation violations are still being observed. These observations included: one (1) chill tray which held cheese was stored directly on the floor of the cheese cave; the inside surface of the cleaned cheese vat contained white residue that was scrapable with the finger; and dried cheese residue pieces were observed on the filler plate of the (b) (4) vacuum packaging machine after the cover was opened. Based on NYSDAM’s current observations, we have concerns about your firm’s ability to implement sustainable corrective actions.

Unapproved New Drugs and Misbranded Drugs
In July 2018, FDA reviewed your website at the Internet addresses http://www.5spokecreamery.com/, which also appears on the product labels for your “5 Spoke Creamery Grass Fed Raw Cow’s Milk Cheese” products.  The claims on your website establish that your “5 Spoke Creamery Grass Fed Raw Cow’s Milk Cheese” products are drugs under Section 201(g)(1)(B) of the Act [21 U.S.C. §321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

“CANCER PROTECTION: Raw milk cheeses from grass-fed cows are very high in conjugated linoleic acid…CLA is among the most potent cancer fighters found in all foods…”

“FIGHTS ALLERGIES: Raw milk has a cortisone-like factor in the cream which aids in combating allergies.”

“Probiotics have shown to improve recovery time for children’s viral diarrhea…reduce inflammation for those with IBD (Inflammatory Bowel Disease).”

“Just to be clear, not all raw milks are created equal.  -fed cows is a source of one of the most potent cancer fighting agent found in foods, Conjugated Linoleic Acid (CLA).”

Your products are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves new drugs on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your “5 Spoke Creamery Grass Fed Raw Cow’s Milk Cheese” products are intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your “5 Spoke Creamery Grass Fed Raw Cow’s Milk Cheese” products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all-inclusive list of the violations that exist in your products and facility.  It is your responsibility to ensure that your products and facility are in compliance with the Act and all applicable laws, including the CGMP regulation.

You should take prompt action to correct these violations cited in this letter. Failure to do so may result in regulatory action without further notice, including without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

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 noncompliance 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 noncompliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any reinspection-related costs.

You should respond in writing within fifteen working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct violations, including an explanation of how your firm plans to prevent the recurrence of the violations described above or the occurrence of similar violations. More specifically, your response should include documentation of the corrective actions your firm has taken. If your firm’s planned corrective actions will occur over time, please include a timetable for implementation of those activities. If corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please include copies of any available documentation demonstrating corrections have been made. If you believe that your products are not 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: W. Martin Rennells, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205.  If you have questions regarding any issues in this letter, please contact W. Martin Rennells at 518-453-2314 x1038.

Sincerely,
/S/
Ronald Pace     
Program Division Director
Office of Human and Animal Food Operations -
East Division 1

Page Last Updated: 11/19/2018
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