FDA
WARNING LETTER
CMS 616288
October 25, 2021
Ms. Gracia Borjas, Production Manager
Dear Ms. Leiberman and Ms. Borjas:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility located at 38 Dobbin Street, Brooklyn, NY 11222, where you manufacture Ready-to-Eat (RTE) chocolate products (including chocolate bars, ganache, hot chocolate, and cookies), and you repack chocolate products (including hot chocolate, brownies, and caramel bonbons), from June 1 through June 17, 2021. 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). At the conclusion of the inspection, FDA issued an FDA Form 483, Inspectional Observations, listing the deviations found at your facility.
Based on FDA’s inspectional findings, we have determined that the RTE chocolate 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 become 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 USC 331(uu)]. You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov/.
We received your response, sent via email on July 6, 2021, which included a summary of corrective actions you have taken or plan to take. After reviewing the inspectional findings and your response to the observations listed in the FDA Form 483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We address your response below.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. You did not prepare, or have prepared, and implement a food safety plan as required by 21 CFR § 117.126(a)(1). The food safety plan must be prepared, or its preparation overseen, by a preventive controls qualified individual and must include the following:
1) The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
2) The written preventive controls, as required by 21 CFR § 117.135(b);
3) The written supply-chain program, as required by Subpart G;
4) The written recall plan, as required by 21 CFR § 117.139(a);
5) The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
6) The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
7) The written verification procedures, as required by 21 CFR § 117.165(b).
2. You did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a). Specifically,
a. You did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard that requires a preventive control. Your facility receives, stores, and manufactures products that contain allergens such as wheat, milk, tree nuts (e.g., hazelnuts, almonds, and pistachios), and soy. Foods containing allergens can cause serious adverse health consequences or death to allergic individuals if they consume a food to which they are allergic. A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as hazards requiring a preventive control.
b. You did not identify and evaluate bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures food with tree nuts (e.g., hazelnuts, almonds, and pistachios) and various chocolates. These ingredients have been associated with pathogens such as Salmonella.
c. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures/processes food with tree nuts (e.g., hazelnuts, almonds, and pistachios). These ingredients have been associated with mycotoxins such as aflatoxin.
d. You did not identify and evaluate contamination with environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether they require a preventive control as required by 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 lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR § 117.165(a)(3)).
3. You did not identify and implement preventive controls for any of your products to provide assurance 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). 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).
For example, food allergen controls include procedures, practices, and processes employed for labeling to ensure that all food allergens are included on the label and that food is protected against allergen cross-contact (see 21 CFR 117.135(c)(2)). You do not have controls in place to adequately control the hazard of undeclared allergens due to incorrect labeling, as evidenced by the following. On December 1, 2020, your facility recalled Cacao Market Cylinder Dark Chocolate Pearls due to undeclared milk on the product label. The recall was initiated after an inspection by the New York State Department of Agriculture and Markets revealed that the Cacao Market Cylinder Dark Chocolate Pearls that were repacked at your facility contained a milk ingredient but did not declare milk on the finished product label. During our inspection, you explained that you had previously produced the product at your facility without milk; however, when you began outsourcing the product from one of your suppliers and repacking the product at your facility, the outsourced product contained milk. You explained that you continued using the same label that did not declare milk. During our inspection, you stated that you hired an employee to ensure that labels are updated when needed to reflect ingredient changes; however, you have no procedures in place to ensure that any needed revisions are implemented.
Further, your facility manufactures multiple products with different allergen profiles, including products that contain tree nuts (e.g., hazelnuts) and that do not contain tree nuts on the same day and on shared equipment, which can result in allergen cross-contact without appropriate controls. You do not have controls in place to adequately control the hazard of allergen cross-contact.
Your response states that you are “developing a Food Safety Plan, including all required preventative controls” and including “a flow diagram of our process, hazard analysis for all raw materials, ingredients, processing aids, and packaging materials, hazard analysis for our production process, and the identification of any process preventative controls.” Further, you state that you are developing procedures “that outline the monitoring, record keeping, corrective action, verification, and validation of all process preventative controls.” In addition, you state that you are “reevaluating our sanitation procedures and processing schedule to allow us to better control our risk of allergen cross contamination. This will include items such as scheduling allergens to be run at the end of the production schedule and fully defined procedures on when and how to break equipment down for proper cleaning.” You state that “This will include a facility wide environmental monitoring program to verify the effectiveness of our sanitation program.” Your response does not include a timeline as to when you will have these corrective actions completed or supporting information or evidence that your facility is currently conducting these corrective actions.
Current Good Manufacturing Practice (Subpart B):
1. You did not keep buildings, fixtures, and other physical facilities in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR § 117.35(a). Specifically,
• The skylight, located above the tempering machine inside the processing room, had apparent loose paint hanging from its metal bars. The tempering machine contained melted dark chocolate and was kept uncovered during the entire inspection.
• The floor inside your processing room exhibited cracked, peeling surfaces.
Your response states that “Loose paint was removed from the metal bars of the skylight,” and “We are evaluating our floor and putting together a plan to repair the areas that need it the most.” However, you did not provide evidence that you have removed the loose paint from the metal bars of the skylight. Additionally, your response does not include a timeline as to when you will have the floor repaired or supporting information to demonstrate that your facility is currently working on conducting corrective actions.
2. You did not clean food contact surfaces as frequently as necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR § 117.35(d). Specifically,
• On June 1, 2021, employees were observed transferring ganache coming out of the cooling tunnel onto previously used disposable plastic trays. These trays were not clean, as food residue was observed on the trays.
• On June 2, 2021, after cleaning was performed on the metal grid, chocolate residue was observed adhered to the metal grid extension which was reattached to the cooling tunnel that was ready for the next shift’s production.
3. You did not take adequate precautions to ensure that production procedures do not contribute to allergen cross-contact and to contamination from any source, as required by 21 CFR § 117.80(a)(4). Specifically,
• On June 1, 2021, you filled, repacked, and labeled two types of hot chocolate, one of which contains the allergen hazelnut. These two products were processed simultaneously, side by side, on the same processing table.
• On June 1, 2021, while a fan was used to cool dark chocolate-filled molds, apparent chocolate dust was observed on many surfaces inside the processing room caused by the fan blowing on the dark chocolate. These surfaces included the pipes running across the ceiling and plastic covering unused equipment. You manufacture different types of chocolate products that may contain different allergens in the same room using the same method to cool the chocolate.
• Your typical practice is to store clean chocolate bar molds on a rack protected by plastic wrap. On June 1, 2021, molds that had chocolate residue within their ridges were observed being stored on the clean mold storage rack. An employee explained that these molds were used to make milk chocolate bars and were placed on the clean rack in error. The employee added that the facility has designated molds for milk and dark chocolate bars; however, these molds are identical. The facility does not have a system in place to monitor cleaning and to differentiate between the two molds.
4. You did not take reasonable measures and precautions to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR § 117.10(b)(3). Specifically, on June 1, 2021, two employees were observed returning to the processing room after taking their break, and they proceeded with processing ganache without washing and sanitizing their hands.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or 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 your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the timeframe within which you will do so.
Section 743 of the FDCA (21 U.S.C. 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 noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection, assessing and collecting the re-inspection fees [21 U.S.C. 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: W. Martin Rennells, Compliance Officer, One Winner’s Circle, Suite 140, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact Mr. Rennells at 518-453-2314 x1038 or willliam.rennells@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations –
East Division 1
