- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMitchell F. Williams
- Greenwood Ice Cream, LLC
4829 Peachtree Rd
Chamblee, GA 30341-3113
- Issuing Office:
- Office of Human and Animal Food Operations – East Division 3
December 17, 2021
RE: CMS #616395
Dear Mr. Williams:
The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) ice cream manufacturing facility located at 4829 Peachtree Rd, Chamblee, GA 30341-3113, from June 22, 2021 through June 25, 2021. 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). During this inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations.
Based on FDA’s inspectional findings and the analytical results for samples collected from your production environment, we have determined that the ice cream 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 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.
We received your response to the FDA-483 on July 19, 2021, and to the environmental findings on August 20, 2021, describing corrective actions taken by your firm. Based on our review of the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. You did not identify and implement preventive controls adequate 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 or misbranded under section 403(w) of the Act [21 U.S.C. § 342 or § 343(w)], to comply with 21 CFR § 117.135(a)(1).
Your facility manufactures ice cream, an RTE food product that is exposed to the environment prior to packaging, where it may be contaminated with environmental pathogens such as L. monocytogenes. The packaged ice cream 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.
Your Hazard Analysis for “(b)(4),” dated January 1, 2019, which covers ice cream products manufactured at your facility, indicates that biological hazards require a preventive control at the processing step of “(b)(4)” because “unwanted pathogens and allergens are likely to occur based on not cleaning equipment properly.” Your hazard analysis indicates that “good cleaning practice” is the preventive control measure applied to significantly minimize or prevent the food safety hazard. However, your hazard analysis indicates that you do not apply a preventive control at this processing step. At this step in your process, RTE inclusions (such as fruit, cookies, sprinkles, and nuts) are added to RTE ice cream products post-pasteurization where they are exposed to the environment before being packaged. As evidenced by the multiple and repeated findings of L. monocytogenes in your production environment (which indicates a resident strain of L. monocytogenes in your facility), you did not identify and implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes, as required by 21 CFR §§ 117.135(a)(1) and (c)(3).
FDA’s inspection included the collection of environmental swabs on June 22, 2021, during the production of RTE vanilla ice cream, and found that eight (8) of eighty-five (85) swabs were positive for L. monocytogenes. Of the positive findings, one (1) swab was collected from an area adjacent to food-contact surface where RTE ingredients were being prepared on the filling table. This was not the first time L. monocytogenes was found in environmental samples collected at your facility. In 2017, FDA detected L. monocytogenes in one (1) environmental swab of a floor drain, and in 2018 FDA detected L. monocytogenes in eight (8) environmental swabs, including from areas adjacent to food-contact surfaces. Furthermore, FDA held a Regulatory Meeting with your firm in 2019, to notify you of our concerns with our inspectional findings, environmental findings, and your corrective actions.
Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples. Based on the results of the WGS analysis, the seventeen (17) isolates comprise three (3) different strains of L. monocytogenes. Of particular significance, fourteen (14) isolates derived from the environmental samples collected at your facility during our 2021, 2018, and 2017 inspections were genetically identical, representing a single strain of L. monocytogenes. Additionally, these fourteen (14) isolates were also genetically identical to three (3) environmental swabs collected by Georgia Department of Agriculture (GDA) during a 2016 inspection of your facility. The presence of the same strain of L. monocytogenes over multiple years is indicative of a resident pathogen or harborage site in your facility since 2016. We advised you of the importance of these WGS results via a conference call on August 3, 2021.
The reoccurring presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation procedures have been inadequate to significantly minimize or prevent L. monocytogenes in your facility. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive, and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites. Given the history of our findings, we continue to be concerned about your ability to maintain a sanitary environment. We recommend that you continue to identify potential harborage sites and source(s) of the organism in your processing environment and implement the necessary methods and controls to ensure L. monocytogenes does not contaminate your environment or your RTE ice cream products.
In your response to our current inspectional findings, you committed to performing corrective actions and indicated that you have cleaned and sanitized your production environment and conducted environmental swabbing to verify the effectiveness of your cleaning. Additionally, you indicated that you plan to increase the frequency of environmental sampling for Listeria spp. to (b)(4) samples, keep a detailed log of the location for your environmental samples, update your cleaning and sanitation procedures, (b)(4) for cleaning and sanitizing operations, and review your process for employee training. However, you did not provide supporting documentation to show that you have implemented these corrective actions. Further, in response to the resident strain of L. monocytogenes identified in your facility, we would strongly encourage you to conduct a root cause analysis to identify any potential niche or harborage areas and to address any potential routes of contamination. We will verify the effectiveness of your corrective actions during our next inspection.
2. You did not establish and implement adequate written verification procedures for environmental monitoring, as required by 21 CFR § 117.165(b)(3).
Your “Environmental Monitoring Program for Sanitation Preventive Control Verification,” dated January 1, 2019, states “Beginning of 2020. Greenwood will do environmental testing on a routine basis with a minimum of (b)(4) per (b)(4). (b)(4) tests per (b)(4). Testing to be (b)(4) to include (b)(4).” Review of your records indicated that you did not collect swabs at this frequency; the last time you collected environmental swabs was November 10, 2020. Additionally, your environmental monitoring procedure did not identify the analytical method(s) used, as required by 21 CFR § 117.165(b)(3)(v). Moreover, you should consider whether the number of samples and frequency of your sampling provide adequate assurance that you are controlling environmental pathogens.
In addition, your corrective action procedures for a positive test result state, “(b)(4)” and “(b)(4) for (b)(4) in addition to the regular testing. Only after a period of (b)(4) will the location be cleared.” Your corrective action procedures do not describe the steps to be taken to ensure that all affected food is evaluated for safety and prevented from entering into commerce, if you cannot ensure that the affected food is not adulterated under section 402 of the Act or misbranded under section 403(w) of the Act, as required by 21 CFR § 117.150(a)(2)(iii)-(iv).
Your response to the FDA-483 stated that you will immediately re-implement the established procedures in your Environmental Monitoring Program and keep a detailed log of the location of all environmental samples taken. However, you did not provide any supporting documentation to show implementation of these changes. We will verify the effectiveness of your corrective actions during our next inspection.
3. Your hazard analysis did not identify and evaluate a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control, as required by 21 CFR § 117.130(a)(1). Specifically,
a. You did not identify and evaluate pathogens in your raw materials or ingredients to determine whether they are a hazard requiring a preventive control. Your facility manufactures various flavors of RTE ice cream products with inclusions such as pecan pieces, pistachios, and frozen strawberries which are added post-pasteurization; therefore, these ingredients do not receive a lethal treatment in your process. These ingredients have been associated with pathogens such as L. monocytogenes and Salmonella. We note that you have not established a supply-chain program, and you do not conduct supplier verification activities.
Your response to the FDA-483 indicated that you would inventory each raw material, identify associated hazards, and establish a supplier approval and audit process. However, you did not provide any copies of your evaluation or your written supply-chain program. We will verify the adequacy of these corrective actions during our next inspection.
b. You did not identify and evaluate undeclared allergens to determine whether they are a hazard requiring a preventive control at your “fill, weighted, labeled, and packaged” step. Your facility manufactures a variety of ice cream products that contain one or more major allergenic ingredients including wheat, milk, eggs, tree nuts (e.g., pecan pieces and pistachios), peanuts, and soy. Furthermore, during the inspection of your facility, our investigators found an ingredient in your Jersey Cookie Monster Ice Cream that contains soy lecithin; however, you did not declare soy as an allergen on the label. As a result of these findings, you conducted a Class II recall for Jersey Cookie Monster Ice Cream on June 28, 2021, due to an undeclared food allergen.
Your response to the FDA-483 stated that you conducted a full label review of all products and will add a statement indicating which products are produced on shared equipment. However, your response does not address the hazard of undeclared allergens on your labels and does not indicate whether you will identify this as requiring a preventive control and establish and implement a preventive control program to control this hazard.
c. You did not identify and evaluate metal to determine whether it is a hazard requiring a preventive control. Your manufacturing process contains several steps where metal-to-metal contact occurs in your processing equipment, including mixing, blending, ingredient feeders, ripple pumps, and choppers. During the inspection of your facility, our FDA Investigators observed that you do not have a metal detector, and you have not established or implemented programs to conduct visual checks of your equipment.
Your response to the FDA-483 stated the challenges you were encountering based on the design of your bulk containers that include a metal ring. Your response also noted that you have incorporated (b)(4) and (b)(4) in your (b)(4) line and will implement a formal visual inspection process for your equipment. However, your response does not indicate whether you will identify the physical hazard of metal as requiring a preventive control and establish and implement a preventive control program to control this hazard.
Current Good Manufacturing Practice (Subpart B):
1. Your plant was not constructed in 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, throughout the inspection FDA investigators observed condensate on the ceiling in the (b)(4) room located directly over production equipment, the (b)(4) sink, and prep tables.
2. Your plumbing was not adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant, as required by 21 CFR § 117.37(b)(2). Specifically, the employee hand washing sink located in the processing area, beside the back employee doorway, drains directly onto the floor. FDA investigators observed water from this sink flow across the floor in a heavy foot traffic area, away from the floor drain.
3. You did not provide adequate ventilation and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces, as required by 21 CFR § 117.20(b)(6). Specifically, FDA investigators observed the ceiling vent located above the prep table in the kitchen to have a heavy accumulation of dust and debris.
4. You did not properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR § 117.20(a)(1). Specifically, on June 23, 2021, FDA investigators observed accumulated retired and in-use equipment, storage racks, wooden pallets, milk crates, metal pans, and stainless-steel pipes to be stored behind the plant. Additionally, a door leading to the processing area was observed open for extended periods of time and flying insects were observed within the facility during the inspection.
Your response to the FDA-483 indicates that you will remove a window to install a new (b)(4) in order to remove steam and eliminate the condensation, (b)(4) the handwashing sink line, and clean the vents on a regular basis. Your response also states that you will review, purge, and throw away any unneeded materials and equipment from the area in the immediate vicinity of your plant. You further stated that you have installed some (b)(4) systems in this area to keep materials up off the ground to discourage a breeding ground for pests and will place a new (b)(4) on this door leading to the processing area. However, you did not provide any supporting documentation to show any changes that have been made. We will verify the adequacy of these corrective actions during our next inspection.
The violations cited in this letter are not intended to be an all-inclusive list of the 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 of 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.
In addition to the violations described above, we offer the following comment:
As you work to address the violations cited in this Warning Letter, we remind you that preventive controls are subject to preventive control management components (i.e., monitoring, corrective actions, verification), as appropriate to ensure the effectiveness of the preventive controls, considering the nature of the preventive control and its role in your facility's food safety system, as required by 21 CFR § 117.140.
We reviewed the regulatory status of the ingredients declared on the labeling of your “Cookie Monster,” “Chocolate Chocolate Chip,” “Banana Pudding,” and “Chocolate Fetish” ice cream products, and the products bear or contain Partially Hydrogenated Oils (PHOs) (i.e., Partially Hydrogenated Palm Kernel oil, Cotton Seed Oil, or Soybean Oil), which, as discussed further below, are unapproved food additives. The regulations pertaining to food additives are located in 21 CFR Part 170.
Any substance intentionally added to a food, such as an ice cream product, must be used in accordance with a food additive regulation approving the substance for that use, unless the substance is deemed GRAS among experts qualified by scientific training and experience to evaluate its safety ("qualified experts") under the conditions of its intended use, or is otherwise exempt from the food additive definition in section 201(s) of the Act [21 U.S.C. 321(s)].
PHOs are the primary dietary source of industrially produced trans fatty acids (IP-TFA). On June 17, 2015, FDA issued its final determination that PHOs are no longer Generally Recognized as Safe (GRAS) for any use in human food and set a compliance period of three years to allow industry time to either reformulate products without PHOs and/or submit a food additive petition to FDA to permit specific uses of PHOs. The agency established a general compliance date of June 18, 2018, and an extended compliance date of January 1, 2021, for foods manufactured with uses of PHOs for which a food additive petition was submitted before June 18, 2019. All of these compliance dates have now elapsed. Foods bearing or containing PHOs may be subject to enforcement action by FDA. See Final Determination Regarding Partially Hydrogenated Oils (Removing Trans Fat) https://www.fda.gov/food/food-additives-petitions/final-determination-regarding-partially-hydrogenated-oils-removing-trans-fat
As explained above, the use of PHOs in your “Cookie Monster,” “Chocolate Chocolate Chip,” “Banana Pudding,” and “Chocolate Fetish” ice cream products is not GRAS. Further, FDA is not aware of any other exemption from the food additive definition that would apply to PHOs for use as an ingredient in your ice cream products. Therefore, PHOs used in this manner are food additives under section 201(s) of the Act and are subject to the provisions of section 409 of the Act [21 U.S.C. 348]. Under section 409, food additives are required to be approved by FDA for their intended uses prior to marketing.
Please notify this office in writing within 15 working days of the receipt of this letter, as to the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing 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 time frame within which you will do so.
Your written response should be sent to LT N’Jere P. English, Ph.D., Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, NE, Atlanta, GA 30309. If you have any questions regarding the content of this letter, please contact LT N’Jere P. English, Ph.D. at 404-669-4450 or email Njere.English@fda.hhs.gov.
Ingrid A. Zambrana
District Director, FDA Atlanta District
Program Division Director
Office of Human and Animal Food Operations – East Division 3
Natalie Adan, Division Director
Food Safety Division
Georgia Department of Agriculture
19 Martin Luther King, Jr. Dr. SW
Atlanta, GA 30334