- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameMr. Miguel Torres
- El Abuelito Cheese, Inc.
607-609 Main Street
Paterson, NJ 07503
- Issuing Office:
- Division of Human and Animal Food Operations East II
June 4, 2020
Dear Mr. Torres:
From January 14, 2020 through February 6, 2020, the United States Food and Drug Administration (FDA) conducted an inspection at your facility located at 607-609 Main Street, Paterson, New Jersey, where you manufacture read-to-eat (RTE) cheese products. During our inspection, 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). Based on FDA’s inspectional findings, we determined that you were not in compliance with the CGMP & PC rule. 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 information relating to the CGMP & PC rule and your responsibilities to comply with the regulation through links in FDA’s web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food.
At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA-483 (FDA-483), Inspectional Observations. Subsequently, we received your firm’s response dated February 17, 2020, which included a description of corrective actions taken by your firm. We have reviewed the documentation and continue to have serious concerns as further described in this letter.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility to 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). Specifically, you did not identify and 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). Your facility manufactures RTE food which is exposed to the environment prior to packaging. 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. Listeria monocytogenes is an environmental pathogen that is a known or reasonably foreseeable hazard for cheeses, in particular soft cheeses such as queso fresco.
2. You did not establish 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, as required by 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). For example, for the processing of RTE foods exposed to the environment, generally sanitation controls are needed to control environmental pathogens such as Listeria monocytogenes. 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 21 CFR 117.130(a)(2);
b. The written preventive controls, as required by 21 CFR 117.135(b);
c. The written supply-chain program, as required by subpart G;
d. The written recall plan, as required by 21 CFR 117.139(a);
e. The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR 117.145(a);
f. The written corrective action procedures, as required by 21 CFR 117.150(a)(1); and
g. The written verification procedures, as required by 21 CFR 117.165(b).
Your response indicates that you are working with a HACCP consultant to develop your food safety plan for your facility. We will assess the adequacy and implementation of your food safety plan during the next FDA inspection. We note that we informed you during the Agency’s previous inspection in May 2019 that your facility lacked a required written food safety plan.
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.
In addition to the violations described above, we offer the following comments:
• During our inspection, FDA collected environmental swabs from various locations throughout your processing areas. FDA laboratory analysis of the environmental sample INV1123037 collected on January 15, 2020 confirmed two (2) swabs positive for Listeria grayi and Listeria innocua; both are non-pathogenic Listeria species (Listeria spp.). One of the positive swabs was collected from a surface adjacent to a food-contact surface on the (b)(4) edges of the (b)(4) conveyor belt. Additionally, FDA laboratory analysis of the environmental sample INV1123040 collected on January 29, 2020 confirmed one (1) swab positive for Listeria innocua. The presence of Listeria spp. indicates that the conditions are conducive for pathogenic Listeria monocytogenes to be present in your facility. You only test your environment for ATP and coliforms; you do not conduct swabbing for Listeria spp., which is an appropriate indicator organism for Listeria monocytogenes. As noted above, Listeria monocytogenes is a known or reasonably foreseeable hazard for cheese; sanitation controls are generally applied to prevent contamination of RTE food such as cheese from the environment, and environmental monitoring for Listeria spp. is usually used to verify these controls.
• During our inspection, our investigators made observations regarding the potential need for the monitoring of certain aspects of your operation, which would need to be assessed when your firm evaluates the need to establish and implement preventive control programs. Specifically, you do not monitor your sanitizer solution to ensure concentration levels are effective for your (b)(4) sanitizer at the production entry door, your (b)(4) of sanitizer containing white rags used to wipe down equipment, or your buckets of sanitizer used to soak utensils.
• We note that part 117 includes requirements for training employees and keeping records of certain training (see 21 CFR 117.4). Your response states that you (b)(4). However, your response does not include details on when this (b)(4) will occur or the records documenting that this (b)(4) was conducted. We will verify the adequacy during our next inspection.
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 response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer.
John F. Sheehan
Baltimore Acting District Director
Program Division Director/
Human and Animal Foods Division II East