- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameScott Edgar Winfrey, Mark Stuart Winfrey, Jillian Winfrey Pallazola
- Winfrey's Olde English Fudge, Inc.
40 Newburyport Turnpike
Rowley, MA 01969-2106
- Issuing Office:
- Division of Human and Animal Food Operations East I
CMS # 636841
Dear Mr. Scott Winfrey, Mr. Mark Winfrey and Ms. Jillian Pallazola:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 40 Newburyport Turnpike, Rowley, MA from March 8, 2022 to April 21, 2022. The inspection covered your ready-to-eat (RTE) enrobed chocolates and fudge, including Milk Chocolate Pretzels and Milk Chocolate Peanut Butter Mini Eggs. 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 violations found at your facility.
Based on FDA’s inspectional findings, we have determined that the RTE enrobed chocolates and fudge 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 United States Codes (U.S.C.) § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they 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)].
Further, we have reviewed product labels that were collected during the inspection and found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your products to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as discussed below.
You may find information relating to the CGMP & PC rule and your responsibilities to comply with this and other FDA regulations through links in FDA’s web page at https://www.fda.gov.
We received your firm’s responses sent via email on April 28, 2022 and May 16, 2022, which included a description of corrective actions taken by your firm. After reviewing the inspectional findings and your responses 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 responses below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
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). The “Food Safety Plan for Molding Milk Chocolate bar” provided during the inspection included a “Risk Assessment” but only for the product “Molded Chocolate Bar.” You have not conducted a Hazard Analysis that covers your enrobed chocolates, including Milk Chocolate Pretzels and Milk Chocolate Peanut Butter Mini Eggs, or fudge products, such as Chocolate Fudge and Peanut Butter Fudge.
a. You did not identify and evaluate the hazard of allergen cross-contact as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. You manufacture multiple products with different allergen profiles on the same day and on shared equipment, which can result in allergen cross-contact without appropriate controls. A knowledgeable person manufacturing/processing food in your circumstances would identify allergen cross-contact as a hazard requiring a preventive control. Preventive controls for food allergens include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact, including during storage, handling and use (see 21 CFR 117.135(c)(2)(i)).
We note that on March 14, 2022, you manufactured Milk Chocolate Peanut Butter Mini Eggs, lot #07322, which contain peanuts, and Milk Chocolate Pretzels, lot #07322, which do not contain peanuts, on the same line using the same chocolate bottom enrober and top enrober with no cleaning in between these products. While you were manufacturing the Milk Chocolate Peanut Butter Mini Eggs, investigators observed pieces of peanut butter falling into the bottom coater chocolate. This chocolate was then used to enrobe the Milk Chocolate Pretzels. The chocolate circulates in these enrobers and is used for products with different allergenic profiles. Therefore, recirculating enrobing chocolate has the potential to become a vehicle for allergen cross-contact.
On March 31, 2022, FDA collected sample 882473, consisting of four 8 oz. portions of Milk Chocolate Pretzels, lot #07322, from your facility's finished product storage area. This lot of Milk Chocolate Pretzels was produced after lot #07322 of Chocolate Peanut Butter Mini Eggs described above. Two sub-samples of this sample were tested utilizing two ELISA test kits, the Neogen Veratox and the R-Biopharm RIDASCREEN. Sub-sample 1 showed results of 280 ppm and 104 ppm peanut according to the Veratox and the RIDASCREEN Peanut ELISAs, respectively. These analytical results were relayed to you on May 13, 2022. The product sampled contained the following statement on its labels: “ALLERGY ALERT: These Candies Contain Traces of: … Peanuts … ” Be aware that labeling products with advisory statements does not relieve you of the responsibility to ensure that you have controls in place to significantly minimize or prevent the unintentional addition of allergens during the manufacturing process.
b. You did not identify and evaluate the hazard of undeclared allergens due to an incorrect label as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. A knowledgeable person manufacturing/processing food in your circumstances would identify undeclared allergens as a hazard requiring a preventive control. Preventive controls for food allergens include procedures, practices, and processes employed for labeling to ensure that all food allergens that are present in the food are included on the label (see 21 CFR 117.135(c)(2)(ii)).
We note that you manufacture Milk Chocolate Peanut Butter Mini Eggs that contain milk, peanuts, and soy and Milk Chocolate Pretzels that contain milk, wheat, and soy. Your procedure titled “Policy & Procedure Manual***Production Area Guidelines” states “(b)(4)” and “(b)(4).” However, this procedure is not adequate because it does not ensure that all food allergens that are present in the food are declared on the product label, and it does not include monitoring or corrective action procedures.
c. You did not identify and evaluate the hazard of contamination with environmental pathogens, such as Salmonella and Listeria monocytogenes, as a known or reasonably foreseeable hazard to determine whether it requires a preventive control, to comply with 21 CFR 117.130(c)(1)(ii). You manufacture RTE enrobed chocolates and fudge which are exposed to the environment at the steps of chocolate melting, weighing/mixing ingredients, forming, chocolate covering, and packaging. The packaged RTE enrobed chocolates and fudge do 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. If you identify environmental pathogens as a hazard requiring a preventive control, you are required to implement preventive controls, such as sanitation controls, to provide assurances that this hazard will be significantly minimized or prevented (see 21 CFR 117.135(c)(3)). Further, if contamination with an environmental pathogen is a hazard requiring a preventive control, you must conduct environmental monitoring to verify that your controls are effective (see 21 CFR 117.165(a)(3)).
We note that although you have procedures in your “Policy & Procedure Manual***Production Area Guidelines” directing that “(b)(4),” these procedures do not provide adequate direction as to how this cleaning should be performed or monitored.
d. You did not identify and evaluate the hazard of bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether they require a preventive control (i.e., supply-chain control) in your ingredients. You manufacture RTE enrobed chocolates and fudge using RTE ingredients such as chocolate and peanut butter. These ingredients have been associated with pathogens such as Salmonella. Although some of your products undergo a process that is “exceptionally lethal” and you would not be able to make the product without significantly minimizing Salmonella (e.g., fudge in which all the ingredients are heated to the high temperatures that allow the fudge to set), this is not the case for all your products. A knowledgeable person manufacturing/processing food in your circumstances would identify bacterial pathogens as a hazard requiring a preventive control for your RTE enrobed chocolate products.
For those RTE products that require a preventive control for bacterial pathogens associated with the ingredients (e.g., RTE chocolate and peanut butter) and that do not undergo adequate lethality within your facility, you are required to establish and implement a supply-chain program to comply with 21 CFR 117.405(a)(1). A supply-chain program includes approving suppliers and conducting appropriate supplier verification activities as described in 21 CFR 117.410. Salmonella in RTE chocolate and peanut butter is a hazard that can cause serious adverse health consequences or death, and thus an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled, 21 CFR 117.430(b). The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter, 21 CFR 117.430(b)(1)(ii). However, you do not approve your suppliers or conduct adequate supplier verification activities for the hazard of Salmonella in RTE chocolate and peanut butter.
e. You did not identify and evaluate the hazard of mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control (i.e., supply-chain control) in your ingredients. You manufacture RTE enrobed chocolates and fudge using RTE ingredients such as peanuts and tree nuts (e.g., walnuts, almonds, and pecans). These ingredients have been associated with mycotoxins such as aflatoxin. Therefore, contamination with mycotoxins is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in these ingredients.
We note that you have not established a preventive control within your facility to address mycotoxins. Therefore, you are required to establish and implement a supply-chain program covering mycotoxins in ingredients used to make RTE enrobed chocolates and fudge, to comply with 21 CFR 117.405(a)(1). However, you do not have a supply-chain program covering mycotoxins.
f. You did not identify and evaluate the hazard of metal as a known or reasonably foreseeable hazard in your process for Milk Chocolate Peanut Butter Mini Eggs to determine whether it requires a preventive control. On March 14, 2022, investigators observed employees using an extruder to manufacture Milk Chocolate Peanut Butter Mini Eggs, lot #07322. This extruder has direct metal-on-metal contact. We note that you do not have a metal detector, and you have not established or implemented programs to conduct visual checks of your equipment.
The failure to have an adequate food safety plan was cited during your prior inspections in 2018 and 2021. FDA’s concerns with your prior responses to these inspections have been relayed as recently as October 7, 2021 by email, and no further response from you addressing FDA’s concerns was received prior to the 2022 inspection. Your responses dated April 28, 2022 and May 16, 2022, responding to the current inspection and sample analytical results, did not address the hazards above. Your responses indicate plans to establish food safety plan systems, but they do not contain specific details and a time frame for doing so.
Additionally, during this inspection, investigators obtained product labeling and manufacturing records for your Milk Peanut Butter Mini Eggs and Milk Pretzels products that you sell in bulk to retail stores. We have reviewed the labeling and found these products are misbranded within the meaning of Section 403 of the Act (21 U.S.C. § 343) as follows:
1. Your products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the common or usual name of the food.
a. The name “Milk Pretzels” is not an appropriate common or usual name or an appropriately descriptive term for this product.
b. The name “Milk Peanut Butter Mini Eggs” is not an appropriate common or usual name or an appropriately descriptive term for this product.
2. Your Milk Peanut Butter Mini Eggs and Milk Pretzels products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the labels fail to bear a complete list of ingredients in the products. For example, these products are manufactured with a dark cocoa confectionery coating ingredient, but this ingredient and/or its sub-ingredients, such as cocoa, vegetable oil, and nonfat dry milk, are not listed on the finished product labels.
3. Your Milk Pretzels product is misbranded within the meaning of section 403(e)(2) of the Act [21U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents in accordance with21 CFR 101.7, in that statement is not expressed in terms of avoirdupois pound and ounce, as required by 21 CFR 101.7(b)(1).
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please respond 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 cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so. 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: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433 or via email at Lillian.email@example.com (preferred). If you have any questions about the content of this letter, please contact Ms. Aveta at 718-662-5576 or email at Lillian.firstname.lastname@example.org.
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1