FDA Issues Warning Letter to AZ Candy Company

An Arizona candy company was issued a Warning Letter by FDA.
The main issues were:
1) In the hazard analysis, they did not evaluate all of the ingredients used in the product.  The hazard analysis must evaluate every ingredient in the process.
2) There was an issue with the environmental monitoring.  I have a little issue here with the FDA's statements.  Environmental monitoring is specific for the facility.  There should not be a need for testing for Listeria in a candy facility.  Not to say environmental monitoring is not needed, however, I would like to see some additional support for the comments FDA is stating in this item.
3) The firm was buying raw nuts and roasting them, but the firm claimed that Salmonella was not a hazard because there was Supplier Control.  But clearly, the firm would have a Process Preventive Control in terms of Roasting.
4) The firm did not have a good pest control program.

From the report, Item 1.
Your hazard analysis for your RTE peppermint snow mints, chocolate pretzel clusters, and cinnamon honey peanut butter did not include an evaluation of all ingredients used to manufacture these products.
Specifically,
a. The hazard analysis for "[Chocolate] Molding," which applies to its use in peppermint snow mints, did not identify or evaluate potential hazards for the ingredient crushed peppermint/candy cane, such as recontamination with environmental pathogens and unapproved colors/additives.
b. The hazard analysis for "[Chocolate] Molding," which applies to its use in chocolate pretzel clusters, did not identify or evaluate potential hazards with the ingredient pretzels, such as recontamination with environmental pathogens.
c. The hazard analysis for (b)(4), which applies to the performance of this activity to make cinnamon honey peanut butter, did not identify or evaluate potential hazards for the ingredient ground cinnamon, such as Salmonella spp. and heavy metals, and for the ingredient honey, hazards such as drug residues and pesticides.



Item 2.
You did not establish and implement adequate written procedures for environmental monitoring, as required by 21 CFR 117.165(b). You manufacture RTE foods such as candies, chocolates, candy-coated popcorn, nuts, taffy and snack foods, which are manipulated by employees and exposed to the environment at numerous stages of manufacturing and do not receive a subsequent control to significantly minimize or prevent environmental pathogens. For example, your peppermint snow mints are exposed to the environment after entering the (b)(4) tank, during the molding process, including employee placement of molds onto a conveyer belt as well as (b)(4) addition of ingredients into a (b)(4), through a (b)(4), when employees remove product from molds (at the "popping" station) and when bulk packaged into boxes. Further, you use (b)(4) peanuts as an ingredient which could be a source of environmental pathogens such as Salmonella. You have identified a "Cleaning and Sanitation Program" (i.e., sanitation controls) as a preventive control to significantly minimize or prevent the hazard of environmental pathogens (identified in your hazard analyses for molding, (b)(4), and roasting). Your environmental monitoring procedure (2.4.8) specifies "6 Salmonella swab tests on equipment and/or stations that come into contact with finished or RTE products on an (b)(4) basis"; however, the number and location of sampling sites as well as frequency of sampling are not adequate to determine whether your sanitation preventive controls are effective. You (b)(4) of equipment in the kitchen, retail, and chocolate production areas. Of these swabs, you (b)(4) swab related to your peppermint snow mints production at the popping station. Further, performing environmental monitoring (b)(4) is not sufficient to determine whether your controls are effective. In addition, you should evaluate whether Listeria monocytogenes is an environmental hazard for your RTE foods that are exposed to the environment and whether you should also conduct environmental monitoring for Listeria spp. to verify sanitation controls.

Item 3.
"You did not 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 you facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1). You receive (b)(4) peanuts from your supplier that are used in your RTE nut butters and milk chocolate peanut clusters. Your hazard analysis for "Roasting" identifies Salmonella as a food safety hazard requiring a preventive control and specifies that this hazard is controlled through your supplier assurance program in which a Certificate of Analysis (COA) is provided by the supplier. The documentation provided by the supplier identifies (b)(4) and indicates that peanut products that have undergone their (b)(4)." (b)(4) and is not a kill step for Salmonella. Furthermore, the (b)(4) peanuts are received with a label that states that " it is recommended that (b)(4) peanuts (b)(4)." There is no indication that your supplier is controlling Salmonella in the (b)(4) peanuts. Therefore, you cannot control the hazard through supplier controls. The (b)(4) peanuts are roasted at your facility. Although roasting is generally a preventive control for Salmonella in (b)(4) peanuts, you do not treat the roasting process as a control for Salmonella. To establish your roasting as a process preventive control, you would need to, among other things, validate that the process is adequate to significantly minimize the hazard (Salmonella) in accordance with 21 CFR 117.160."

Item 4
You did not take effective measures to exclude pests from your food plant and to protect against contamination of food by insects, as required by 21 CFR 117.35(c). Specifically, on August 19-20, 2019, the following conditions were observed: [a lot of rodent poop was found in various parts of the facility].


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cerreta-candy-company-inc-593983-01212020
Cerreta Candy Company, Inc.
MARCS-CMS 593983 — January 21, 2020
Reference #:  DEN-20-03-WL
Product:  Food & Beverages

Recipient:
Jonathan D. Cerreta
Vice President
Cerreta Candy Company, Inc.
5345 W. Glendale Ave
Glendale, AZ 85301
United States
Issuing Office:
Office of Human and Animal Foods – Division IV West
United States

January 21, 2020
WARNING LETTER

Ref:# DEN-20-03-WL
Dear Mr. Cerreta:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 5345 W. Glendale Ave, Glendale, Arizona, from August 19, 2019 to August 26, 2019. The inspection covered your ready-to-eat (RTE) candies and snack food products and revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC Rule) in Title 21, Code of Federal Regulations Part 117 (21 CFR 117).
During our inspection of your facility, FDA investigators found serious violations of the CGMP & PC rule. Based on FDA's inspectional findings, we have determined that the RTE 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 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links on FDA's home page at http://www.fda.gov.
On August 26, 2019, at the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found in your manufacturing operations. We received your response dated September 13, 2019, which included a summary of corrective actions taken and planned by your firm. The adequacy of your firm 's promised corrective actions is discussed below and implementation of those actions will be assessed during our next inspection.

Hazard Analysis and Risk-Based Preventive Controls (Subparts C and G):
1. Your hazard analysis did not 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)(1). Your hazard analysis for your RTE peppermint snow mints, chocolate pretzel clusters, and cinnamon honey peanut butter did not include an evaluation of all ingredients used to manufacture these products.
Specifically,
a. The hazard analysis for "[Chocolate] Molding," which applies to its use in peppermint snow mints, did not identify or evaluate potential hazards for the ingredient crushed peppermint/candy cane, such as recontamination with environmental pathogens and unapproved colors/additives.
b. The hazard analysis for "[Chocolate] Molding," which applies to its use in chocolate pretzel clusters, did not identify or evaluate potential hazards with the ingredient pretzels, such as recontamination with environmental pathogens.
c. The hazard analysis for (b)(4), which applies to the performance of this activity to make cinnamon honey peanut butter, did not identify or evaluate potential hazards for the ingredient ground cinnamon, such as Salmonella spp. and heavy metals, and for the ingredient honey, hazards such as drug residues and pesticides.
Although you stated in your response that you have revised your hazard analysis for each of the production processes and evaluated each ingredient and process step to ensure any hazards are being controlled, you did not provide this documentation in your response, so we are unable to evaluate the adequacy of these corrections.
2. You did not establish and implement adequate written procedures for environmental monitoring, as required by 21 CFR 117.165(b). You manufacture RTE foods such as candies, chocolates, candy-coated popcorn, nuts, taffy and snack foods, which are manipulated by employees and exposed to the environment at numerous stages of manufacturing and do not receive a subsequent control to significantly minimize or prevent environmental pathogens. For example, your peppermint snow mints are exposed to the environment after entering the (b)(4) tank, during the molding process, including employee placement of molds onto a conveyer belt as well as (b)(4) addition of ingredients into a (b)(4), through a (b)(4), when employees remove product from molds (at the "popping" station) and when bulk packaged into boxes. Further, you use (b)(4) peanuts as an ingredient which could be a source of environmental pathogens such as Salmonella. You have identified a "Cleaning and Sanitation Program" (i.e., sanitation controls) as a preventive control to significantly minimize or prevent the hazard of environmental pathogens (identified in your hazard analyses for molding, (b)(4), and roasting). Your environmental monitoring procedure (2.4.8) specifies "6 Salmonella swab tests on equipment and/or stations that come into contact with finished or RTE products on an (b)(4) basis"; however, the number and location of sampling sites as well as frequency of sampling are not adequate to determine whether your sanitation preventive controls are effective. You (b)(4) of equipment in the kitchen, retail, and chocolate production areas. Of these swabs, you (b)(4) swab related to your peppermint snow mints production at the popping station. Further, performing environmental monitoring (b)(4) is not sufficient to determine whether your controls are effective. In addition, you should evaluate whether Listeria monocytogenes is an environmental hazard for your RTE foods that are exposed to the environment and whether you should also conduct environmental monitoring for Listeria spp. to verify sanitation controls.
In your written response you committed to revising your environmental monitoring program and indicated you would conduct a study of (b)(4) in your facility to evaluate the potential risk of environmental pathogens such as Salmonella, E. coli, and Listeria. We are unable to evaluate the adequacy of your intended corrective action as you did not include the study of your facility or a revised environmental monitoring program.
3. You did not 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 you facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1). You receive (b)(4) peanuts from your supplier that are used in your RTE nut butters and milk chocolate peanut clusters. Your hazard analysis for "Roasting" identifies Salmonella as a food safety hazard requiring a preventive control and specifies that this hazard is controlled through your supplier assurance program in which a Certificate of Analysis (COA) is provided by the supplier. The documentation provided by the supplier identifies (b)(4) and indicates that peanut products that have undergone their (b)(4)." (b)(4) and is not a kill step for Salmonella. Furthermore, the (b)(4) peanuts are received with a label that states that " it is recommended that (b)(4) peanuts (b)(4)." There is no indication that your supplier is controlling Salmonella in the (b)(4) peanuts. Therefore, you cannot control the hazard through supplier controls. The (b)(4) peanuts are roasted at your facility. Although roasting is generally a preventive control for Salmonella in (b)(4) peanuts, you do not treat the roasting process as a control for Salmonella. To establish your roasting as a process preventive control, you would need to, among other things, validate that the process is adequate to significantly minimize the hazard (Salmonella) in accordance with 21 CFR 117.160.
4. You did not implement a risk-based supply-chain program for those raw materials and other ingredients for which you have identified a hazard requiring a supply-chain-applied control as required by 21 CFR. 117.405(a)(1). Specifically:
a. You identified in your hazard analysis for "Roasting" a "Supplier Assurance Program" as the preventive control for pathogens in tree nuts such as almonds, pecan halves, cashews, filberts, and Brazil nuts, but you have not established supplier verification activities in accordance with 21 CFR part 117 subpart G for your suppliers of tree nuts.
b. You identified in your hazard analysis for "[Chocolate] Molding" a "Supplier Assurance Program" as the preventive control for natural toxins and for pesticides in raisins; your hazard analysis states that the product is received from a "supplier who only receives product and services from partners that are required to act in accordance with all applicable federal, state, and local laws and regulations," but you did not specify any supplier verification activities. This was also the case for pathogens, natural toxins, and pesticides in dried cranberries.

Although your written response stated you are obtaining documentation proving the hazards associated with the raw materials are being eliminated by your supplier; you did not provide these documents in your response, so we are unable to evaluate the adequacy of your corrective action.
5. You did not document the monitoring of allergen preventive controls, as required by 21 CFR 117.145(c)(1).
a. Your Product Tracking Sheet records from January to August 2019 show that you manufactured both peanut butter and almond butter on January 9, February 11, April 11, 2019, April 29, June 12, and July 2, 2019. Your procedure 2.8.1 Allergen Management for Food Manufacturing states in section 2.8.1.8 that (b)(4), labels are gathered with ingredients and approved by a production manager" and " [t]inished product is inspected by production manager (b)(4)." However, you did not document on your Product Tracking Sheet or any other monitoring record maintained by your firm that labels were approved (b)(4) and that finished products were inspected (b)(4) in order to significantly minimize or prevent the hazard of undeclared allergens due to incorrect labeling.
b. Your procedure 2.8.1 Allergen Management for Food Manufacturing, states in section 2.8.1.6 "[i]f a changeover between allergen[ s] becomes necessary, all equipment, utensils, and food contact surfaces are to be properly and effectively cleaned and sanitized." Your firm manufactured both peanut butter and almond butter on January 9, February 11, April 11, April 29, June 12, and July 2, 2019; however, your (b)(4) Cleaning and Sanitation Tracking records did not document that cleaning/sanitation of the (b)(4) occurred between the production of peanut and almond butter on four of these six dates (February 11, April 11, June 12, and July 2, 2019), and you could not locate the (b)(4) Cleaning and Sanitation Tracking record for April 29, 2019.
Although you stated in your response that you have updated the Product Tracking Sheets to include start times for production, packaging, and cleaning and sanitation processes, you did not provide these documents in your response, so we are unable to evaluate the adequacy of your changes.
Current Good Manufacturing Practice (Subpart B):
You did not take effective measures to exclude pests from your food plant and to protect against contamination of food by insects, as required by 21 CFR 117.35(c). Specifically, on August 19-20, 2019, the following conditions were observed:
a. In the ambient storage room where boxes, packing materials, label rolls, and various other pieces of equipment are stored, apparent rodent excreta pellets (AREPs) were observed on the floor along the east wall and in front of the west wall, which appeared to be rodent damaged. A gap of approximately two inches was observed at the bottom of the double doors located on the south side of the ambient storage area. Because these double doors exit to the exterior of the building, the gap provides an entry for rodents and other pests.
b. In the cold room where raw materials and finished products are stored, apparent rodent gnaw marks were observed on the corner of (b)(4) boxes of jumbo runners/peanuts, on a piece of milk chocolate raspberry candy, and on the wrappers of a partially opened box of individually-wrapped one-ounce milk chocolate bars.
c. AREPs were observed in the cold room on the floor behind and on the bottom of one pallet of jumbo runners/peanuts, on top of a pallet of cashews stored beside the peanuts, on the floor along the south wall where pallets with boxes of bulk finished product and in-process materials were stored, on the bottom shelf along the north wall toward the east side of the cold room where finished/packaged products are stored, on the bottom shelf in the middle of the north wall, and in the northeast corner where boxes of chocolate candies and packing materials are stored.
d. A pallet containing apparent re-work material of peppermint snow mints in the cold room was observed to have AREPs inside the box and outside of the plastic bag containing the product.
e. Apparent rodent gnaw marks were observed on a bag of un-popped corn kernels in the production area on the south side of the facility near the kitchen where popcorn, caramels, and various other products are manufactured. AREPs were observed underneath a table adjacent to where the kernels were stored.
f. A gap of approximately two inches was observed at the bottom of the double doors located on the south wall of the receiving area. These double doors exit to the exterior of the building, and the receiving area opens directly into the production area.
During the inspection, you cleaned areas where AREPs were observed, repaired damaged areas of the walls and gaps found in the doors that exit the building, and voluntarily destroyed product with suspect rodent activity, including raw materials and finished product. Your written response further indicates you will be monitoring for rodent activity and are conducting (b)(4) inspections for pest activity. Implementation of these corrective actions will be verified during the next inspection.
(b)(4)
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operations and the products that you distribute are in compliance with the law.
(b)(3)(A).
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 that your firm 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 respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct these deviations, including an explanation of how your firm plans to prevent these violations or similar violations from occurring again. More specifically, your response should include documentation of the corrective actions your firm has taken. If your firm 's planned corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which these activities will be completed. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
Section 743 of the Act (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 and 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Kathy Tormey, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Tormey at Kathleen.tormey@fda.hhs.gov or (303) 236-3137 if you have any questions about this matter.

Sincerely,
/S/
LaTonya M. Mitchell
Program Division Director
Office of Human and Animal Foods -
Division IV West