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WARNING LETTER

Golden Grains Bakery MARCS-CMS 688860 —

Delivery Method:
UPS OVERNIGHT MAIL
Product:
Food & Beverages
Recipient:
Recipient Name
Marc L. Singer, Owner
Recipient Title
Ronald L. Nadel, Owner
Golden Grains Bakery

547 Griffith Road
Charlotte, NC 28217-3517
United States

Issuing Office:
Human Foods Program

United States

December 20, 2024

WARNING LETTER

Reference: CMS Case 688860

Dear Messrs. Singer and Nadel:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) food manufacturing facility located at 547 Griffith Road in Charlotte, NC from June 17, 2024, through June 20, 2024. The inspection of your smoothie “Blender Bomb” processing operations revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). 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 21 CFR Part 117) is prohibited by section 301(uu) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 331(uu)]. You may find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.

At the conclusion of the inspection, FDA investigators issued an FDA Form 483, Inspectional Observations (FDA 483), listing the deviations found at your facility. We received your response to the FDA 483 via email on July 15, 2024. After reviewing the inspectional findings and your response, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We address your response below.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):

1. You did not conduct a hazard analysis to identify and evaluate a known or reasonably foreseeable hazard to determine whether it requires a preventive control, as required by 21 CFR 117.130(a)(1). This is a repeat violation from our May 20-24, 2019, and September 13-17, 2021, inspections of your facility.

Specifically, the hazard analysis contained in your Food Safety Plan for Cold Pressed (Unbaked Products), dated October 17, 2022 (“food safety plan”), did not consider vegetative bacterial pathogens as a known or reasonably foreseeable hazard for coffee, hemp seeds, and chia seeds to determine whether they require a preventive control. You contract manufacture RTE “Java Jolt Blender Bombs” containing these ingredients, which have been associated with vegetative bacterial pathogens (such as Salmonella spp.). These ingredients do not receive a lethal treatment in your facility. A knowledgeable person manufacturing food in your circumstances would identify vegetative bacterial pathogens as a hazard requiring a preventive control in coffee, hemp seeds, and chia seeds. Therefore, you are required to identify and implement preventive controls for the hazard of vegetative bacterial pathogens in these ingredients used in manufacturing. Moreover, a facility that identifies RTE raw materials, which do not receive a lethal treatment at the facility where they are used as ingredients, but which require a supply-chain control, must establish and implement a risk-based supply-chain program for those raw materials. Alternatively, a validated lethal treatment must be established and implemented at the facility.

Although you have established a risk-based supply-chain program that requires that all ingredients, including coffee, hemp seeds, and chia seeds, be sourced exclusively from suppliers approved through your supplier approval program, our inspection revealed that you had not approved the supplier of the coffee being used to manufacture “Java Jolt Blender Bombs” (see 21 CFR 117.415(a)(1)).

We reviewed your written response dated July 15, 2024, including the revised hazard analysis you provided. Your revised hazard analysis identifies Salmonella spp. in ingredients such as coffee, hemp seeds, and chia seeds as requiring a preventive control. With your response, you also included finished product testing results for Salmonella spp. If you verify control of vegetative bacterial pathogens in a raw material or other ingredient via a supply-chain program, note that Salmonella 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 (see 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 (see 21 CFR 117.430(b)(1)(ii)).

Your response also states your commitment to “(b)(4).” We will verify the adequacy and implementation of your corrective actions (including the revised hazard analysis, supplier verification activities, and supplier approval) during a subsequent FDA inspection.

2. You did not implement your preventive controls in your food safety plan 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, as required by 21 CFR 117.135(a)(1). Specifically:

a. You did not implement your preventive control for the metal hazard. Your manufacturing process for RTE smoothie “Blender Bombs” contains steps where (b)(4) occurs in your processing equipment, including your mixer, Vemag, and extruder. Your food safety plan identifies “(b)(4)” as a hazard requiring a preventive control of “(b)(4)” of the manufacturing process.

Further, your Metal Detection Steps and Procedures document, dated June 1, 2020, describes the metal detection controls you intend to follow. Your facility was processing RTE “Java Jolt Blender Bombs” using equipment with (b)(4) during the inspection, but you acknowledged that your facility was not implementing the metal detection controls for that product. Review of your facility’s metal detection records confirmed that “Blender Bomb” products had not undergone metal detection since January 22, 2024.

During the inspection, you also acknowledged that intermittent metal detector failures occurred throughout 2023 that were not documented. The equipment failures affected other products you manufacture, such as dinner rolls, that should have undergone metal detection. For instance, on July 23, 2023, you received a consumer complaint indicating that a metal pin was found in a dinner roll from production lot 23202. Your facility investigated the complaint and determined that the metal object was a stapler pin from an ice bag that had been placed into the mixing bowl. Your Metal Detection Steps and Procedures document states that “(b)(4).” The dinner rolls are not packaged in foil trays or pouch sealed with metal clips and therefore should have undergone metal detection in accordance with your procedures. Your production records for lot (b)(4) did not reflect that the products underwent metal detection. Further, you stated that the dinner roll product did not undergo metal detection during that timeframe because the metal detector was faulty and operated intermittently. These equipment deficiencies were not documented on any of your metal detection records from July 2023 to January 2024 that were reviewed during the inspection, as the records showed consistent passing values with no failures or deviations noted. Deficiencies in metal detection recording-keeping were also observed during our May 2019 inspection. Additionally, during the September 2021 inspection, we observed that you did not monitor your “Blender Bombs” for metal using a metal detector or any other method.

We reviewed your response, including the video you sent showing products being sent through a machine, which was presumably a metal detector. Although your response indicates that this machine was a metal detector, and you provide a metal detector drawing (dated November 19, 2015) that presumably depicts the equipment shown in the video, the video does not provide a complete view of the equipment to allow us to confirm what is being shown. Further, you did not provide any metal detection monitoring records to document the results of the metal detection activity purportedly being shown in the video.

Your response further states that “(b)(4).” In addition, your response indicates that you plan to source a backup metal detector. Your response also asserts that additional training on good documentation practices, corrective and preventive actions, and internal and external audits will be provided to your quality assurance supervisor and a back-up employee, and that when the quality assurance supervisor is unavailable, you will source a weekly review of metal detection records to a PCQI consultant. We will verify the adequacy and implementation of your corrective actions during the next FDA inspection.

b. You did not implement your sanitation preventive control for the environmental pathogens hazard. Your food safety plan identifies environmental pathogens as a hazard requiring a preventive control at various processing steps, such as mixing, tumbling, coating, and packaging, where the RTE “Java Jolt Blender Bombs” are exposed to the environment. These steps occur prior to your products being sealed. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.

Specifically, during the inspection, our investigators observed the following:

i. Your SSOP-General Cleaning and Sanitation procedures require that equipment and utensils be rinsed in a sanitizer sink with an approved sanitizer following cleaning. However, on June 17, 2024, during the production of RTE “Java Jolt Blender Bombs,” a production employee left the line to wash a black bin in the three-compartment sink but did not sanitize it. The un-sanitized bin was then used to store unpackaged RTE Blender Bombs.

ii. You did not follow the corrective actions outlined in your Environmental Monitoring – Listeria procedures, dated June 1, 2021, when you were notified of a presumptive positive Listeria spp. finding on August 24, 2023, for which your facility waived confirmation. According to your Environmental Monitoring – Listeria procedures in effect at the time, when a positive Listeria spp. result occurred, your facility would conduct follow-up environmental sampling that consisted of “(b)(4) swabs total; (b)(4) swabs a day taken on (b)(4) consecutive production days” and send the swabs to a third-party laboratory for analysis. However, your Microbiological Swab Test Logs from August 24-26, 2023, showed that a total of only (b)(4) swabs were taken ((b)(4) swab per day) instead of the required (b)(4) swabs total. Furthermore, instead of sending the swabs to your third-party laboratory for analysis, you tested the swabs in-house.

In your response, you indicate that production employees were retrained internally, and you provide training records. Your response further states that a third-party sanitation team would be sourced to “train and take over the facility,” although the timeframe within which you plan to implement these corrective actions is unclear.

Your response also indicates that you have revised the corrective actions you initiate when a positive Listeria spp. result is found. Your Listeria Environmental Pathogen Management Program document, dated July 12, 2024, shows that since the Listeria spp. presumptive positive finding in 2023, your facility has changed its corrective actions for presumptive positive Listeria spp. results from obtaining (b)(4) swabs total ((b)(4) swabs per day for (b)(4) consecutive days) to obtaining only (b)(4) swabs total ((b)(4) swab per day for (b)(4) consecutive days). Your response does not provide a rationale for adopting the less stringent swabbing response when a positive Listeria spp. result is found during routine sampling. We will verify the adequacy and implementation of your corrective actions during the next FDA inspection.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with the products you manufacture and contract manufacture. 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.

In addition, we offer the following comments:

  • Your food safety plan has not been signed and dated by an owner, operator, or agent in charge, as required by 21 CFR 117.310.
  • All packaged foods regulated by FDA under the Act must comply with the food allergen labeling requirements of the Food Allergen Labeling and Consumer Protection Act of 2004. Allergen ingredients must be listed on the label in one of two ways:

1. Include the name of the food source in parenthesis following the common or usual name of the major food allergen in the list of ingredients in instances when the name of the food source of the major food allergen does not appear elsewhere in the ingredient statement for another allergenic ingredient.
OR
2. Place the word “Contains,” followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in a type size that is no smaller than that used for the ingredient list.

You contract manufacture the product Molly Bz Straight Fire Gourmet Cookies, which lists egg, milk, soy, and wheat ingredients in the ingredient statement. However, the “Contains” statement included on the product label is incomplete in that it lists the egg, milk, and wheat allergens but not the soy allergen. If a “Contains” statement is used on a food label, the statement must include the names of the food sources of all major food allergens used as ingredients in the packaged food.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 corrective actions within 15 working days, state the reason for the delay and the time 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.

If you have questions concerning this letter, you may contact Mrs. Morton at 404-253-1285 or at the noted email address. Please send your written response via email to Lakisha N. Morton, Compliance Officer at Lakisha.Morton@fda.hhs.gov or to the U.S. Food and Drug Administration, Attention: Lakisha N. Morton, Compliance Officer, Office of Compliance and Enforcement, Office of Enforcement, Division of Conventional Foods Enforcement (HFS-607) at 5001 Campus Drive, College Park, MD 20740. Please reference #688860 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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