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WARNING LETTER

U.S. Dairy Unlimited, LLC MARCS-CMS 590413 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Ury Zyman
Recipient Title
Owner
U.S. Dairy Unlimited, LLC

1066 NW 21st St
Miami, FL 33127-4514
United States

Issuing Office:
Office of Human and Animal Foods Division 4 East

United States


November 19, 2019

WARNING LETTER

20-HAFE4-WL-03/CMS No. 590413

Dear Mr. Zyman:

The United States Food and Drug Administration (FDA) inspected U.S. Dairy Unlimited, LLC., a ready-to-eat (RTE) cheese manufacturing facility, located at 1066 NW 21st ST, Miami, FL, from June 24, 2019 to July 3, 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). FDA’s inspection resulted in the issuance of an FDA Form 483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. To date we have not received a response addressing the issues presented to you during inspection and listed in the Form FDA-483.

Based on FDA’s inspectional findings, we determined that cheese products manufactured in your facility 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 were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or 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 http://www.fda.gov.

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

1. You did not conduct a hazard analysis for any of your products. Specifically, you did not identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a). In particular,

a. You did not identify the biological hazards of pathogen survival of a lethal treatment and pathogen growth due to a lack of time/temperature control during the manufacture of your cheese products and storage of finished cheese products as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. During the inspection we observed that you were not following your time and temperature pasteurization parameters of (b)(4) degrees Fahrenheit for (b)(4) minutes. Additionally, we did not observe firm employees monitoring the temperature of the product post-pasteurization and of coolers for finished product storage.

b. You did not evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, to determine whether environmental pathogens are a hazard requiring a preventive control to comply with 21 CFR § 117.130(c)(1)(ii). Specifically, your facility manufactures RTE food which is exposed to the environment prior to packaging. After your products undergo a lethal treatment (pasteurization), they are exposed to the environment before being packaged. The packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.

c. You did not identify the physical hazard of metal as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. While your firm was in operation during our inspection, we observed the use of utility knifes to open powdered ingredients prior to pasteurization, metal wires used in cutting the RTE cheese, and metal staples for sealing the packaged boxes of RTE cheese.

d. You did not identify undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control. Your facility manufactures cheese products in which milk and milk-containing products are used as ingredients.

2. You did not 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 of the Act or misbranded under section 403(w) of the Act [21 CFR § 117.135(a)(1)]. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135). Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140).

3. You did not prepare or have prepared and did not implement a written food safety plan for any of the products manufactured in your facility, as required by 21 CFR § 117.126(a)(1). A food safety plan must include the following:

     a. The written hazard analysis, as required by § 117.130(a)(2);
     b. The written preventive controls, as required by § 117.135(b);
     c. The written supply-chain program, as required by subpart G;
     d. The written recall plan, as required by § 117.139(a);
     e. The written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a);
     f. The written corrective action procedures, as required by § 117.150(a)(1); and
     g. The written verification procedures, as required by § 117.165(b).

Current Good Manufacturing Practice (Subpart B):

1. Your plant was not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR § 117.20(b)(4). Specifically, we observed:

     a. Condensate dripping onto the inverting perforated stainless steel vessels containing molds packed with RTE soft white cheese.
     b. Condensate dripping onto stainless steel molds containing RTE cheese and sanitized flexible blue mold liners used inside round molds for RTE cheese.
     c. Condensate dripping from the cooling system onto acrylic sheets located above the racks and then onto the molds and vessels containing the RTE cheese.
     d. Condensate dripping from the ceiling onto the inverting vessels storing the RTE cheese.

2. You did not maintain your plant in a clean and sanitary condition and in repair adequate to keep food from becoming adulterated, as required by 21 CFR § 117.35(a). Specifically, we observed:

     a. During the removal of RTE soft white cheese from the stainless-steel molds, a firm employee was observed banging the molds against the handle of a metal platform cart in order to loosen the RTE soft white cheese from its mold. During this process, the RTE soft white cheese came in direct contact with the handle of the metal platform cart. The metal handles were observed to have indentations with non-smooth cleanable surfaces. The (b)(4) pipe which transports the pasteurized liquid cheese product into the mixing tank was corroded and filthy with what appeared to be food debris accumulated over time and was leaking liquid cheese product freely onto the floor.
     b. The pipes under the hand wash stations in the Packing Room and Production Area were leaking waste water directly onto the floor.
     c. The (b)(4) sink in the Packing Room was not used properly for washing utensils and equipment. A (b)(4) ladder was placed into the third compartment after being used during packing. No detergent or sanitizer was observed at the (b)(4) sink.

3. You did not clean your non-food contact surfaces in a manner and as frequently as necessary to protect against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR § 117.35(e). Specifically, we observed your employees using a (b)(4) hose to spray water onto the manufacturing room floor and into a floor drain to remove food debris. Water from the floor was splashing all around and directly on the vessels containing RTE soft white cheese product.

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 re-inspection 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.

Your written response should be directed to the Food and Drug Administration, attention to: Mr. Ramon Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact, Ms. Marilyn Santiago, Compliance Officer, at (787) 729-8707 or via email at Marilyn.santiago@fda.hhs.gov.

Sincerely,
/S/

Ramon A. Hernandez
District Director | FDA San Juan District
Program Division Director
Office of Human and Animal Food Operations-
East Division 4