Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cerreta-candy-company-inc-537087-09132017
Timestamp: 2020-08-05 01:59:07
Document Index: 485083942

Matched Legal Cases: ['art 110', 'art 110', '§ 342', '§ 343', '§ 343', '§ 343', '§ 379', '§ 379']

Cerreta Candy Company, Inc. - 537087 - 09/13/2017 | FDA
Cerreta Candy Company, Inc. - 537087 - 09/13/2017
Cerreta Candy Company, Inc. MARCS-CMS 537087 — September 13, 2017
James J. Cerreta
1 Denver Center, Building 20
James J. Cerreta, President
Ref: HAFW4(DEN)-17-20-WL
On August 1-4 and 7-8, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your confectionery and candy manufacturing facility located at 5345 West Glendale Ave, Glendale, Arizona. The inspection and sample collection revealed serious violations of the regulations of 21 Code of Federal Regulations Part 110 (21 CFR Part 110), Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. Accordingly, we have determined that your candy products 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 have been 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. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
During our inspection, we observed the following:
1) You failed to maintain buildings, fixtures and physical facilities in repair sufficient to prevent food from becoming adulterated as required by 21 CFR 110.35(a). Specifically,
A clamp with a build-up on an unknown black and brown material was observed contacting the uncovered Peppermint Snow Mints, lot #2147, as the plastic molds moved along the (b)(4) conveyor.
During cleaning of the “(b)(4) caramel cooker”, the spraying water splashed back onto the equipment, during the sanitation process, from the nearby wall and used floor mop hanging from the wall.
A coarse build-up of an unknown grey and black particulate was observed in the uncovered vent opening located directly above the exposed “(b)(4) caramel cooker”. Your firm was actively utilizing this piece of manufacturing equipment for rice crispy mixture on August 1, 2017.
A build-up of an unknown black material, with adhering particulate, was observed above exposed Peppermint Snow Mints lot #2147 as they moved along the (b)(4) conveyor.
A build-up of unknown black and grey particulate adhered to the white fans pointed at the (b)(4) conveyor line used to cool Peppermint Snow Mints.
A build-up of an unknown black and grey particulate adhered to the fluorescent lights and ceiling tiles located above the (b)(4) cutting table. Various taffy flavors and caramels are processed on this uncovered (b)(4) table.
We have received your response letter dated August 17, 2017, and find your response to be inadequate. For example:
You provided a picture of the new clamp and proposed an updated cleaning schedule which were not provided in your written response. Additionally, the new clamp is not constructed with smooth and seamless surfaces.
Your response indicates this piece of equipment was washed and sanitized. Your response does not indicate the practice has been altered, or provide the cleaning/sanitization procedure utilized to mitigate the observation.
Your response indicates the vent opening has been cleaned; however, you did not provide evidence of the cleaned vent. Additionally, you did not provide a filled out “Sanitation List” to display how adding these areas to your documentation mitigates the issues noted during the inspection. Therefore, the adequacy of this correction cannot be determined at this time.
You stated the (b)(4) conveyor has been added to your firm’s “Sanitation List” for (b)(4) cleanings. You have not provided evidence that (b)(4) cleaning of these areas is adequate to control build-up of particulate.
You provided evidence that the fans will be cleaned (b)(4), and recorded on the “Sanitation List.” Further, this issue was brought to your firm’s attention during the FDA inspection ending on August 28, 2015. You did not provide evidence that this frequency will mitigate the issues observed during the inspection.
The pictures provided with the response appear to adequately address the immediate cleaning concerns. The sustainability of your actions will be evaluated during the next inspection.
2) You failed to provide effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests as required by 21 CFR 110.35(c). Specifically,
A live four millimeter German cockroach (Blattella germanica (L.)) was collected as sample INV981742 from the ground under the milk chocolate enrobing equipment located near the center of the manufacturing area. Additionally, a live apparent cricket was also found beneath this piece of equipment.
A dead rodent was found along the cat-walk of the finished product packaging storage, and approximately 50 apparent rodent excreta pellets were found under shelves in the northwest corner of the finished goods/cold room. These two storage areas lack physical barriers leading into the manufacturing areas.
A dead apparent cockroach was found on a finished product storage shelf approximately one inch away from Milk Chocolate Walnut Fudge Week/Lot# 11/17-1997.
We have received your response letter dated August 17, 2017, and find your response to be inadequate. For example, you state that your pest control and sanitation program have been revised, and now include new procedures. You state that your firm has been in contact with your current pest control service company, and have established a new scope of service with them. You did not provide evidence of the updated pest control or sanitation programs implemented in response to the observations cited in the FDA 483.
3) You failed to ensure the design and materials of equipment and utensils allows for proper cleaning and maintenance as required by 21 CFR 110.40(a). Specifically,
The (b)(4) table tops, utilized for taffy and caramel manufacturing, contain cracks, divots, and holes in them. These damaged areas expose rough surfaces of the underlying material.
The conveyor belts on the (b)(4) line and the (b)(4) line contain areas of missing material and worn edges exposing the underlying porous material. A variety of chocolate-coated products are produced utilizing these pieces of equipment.
Metal band clamps were found on the thermometer probes of the (b)(4) caramel mixers that were in the process of manufacturing a rice crispy mixture and caramel. The bands contain numerous holes, and the clamping mechanism does not contain smooth surfaces. The location of the clamps causes them to be food contact surfaces. Additionally, these same types of clamps were found inside the (b)(4) utilized to manufacture taffy and cream products.
We have received your response letter dated August 17, 2017, and find your response to be inadequate. For example,
You state the (b)(4) table tops are in the process of being refinished by an outside contractor; however, no documentation was provided with your response to indicate this action has been undertaken. Additionally, you have not provided documentation detailing the actions your firm has implemented to ensure the sustainability of this correction.
You provided a “Quotation Form” displaying the purchase of and installation of a new conveyor belt. However, the observation listed deficiencies found on two different pieces of chocolate (b)(4) equipment.
You state that hose clamps will be removed from the food manufacturing equipment. Your response does not indicate how the use of the clamps will be ceased for the future, nor do you provide photographic evidence of their removal.
4) You failed to take effective measures to protect against the inclusion of metal and extraneous material in food as required by 21 CFR 110.80(b)(8). Specifically,
The metal mixing paddles utilized on the (b)(4) caramel cookers had grooves in the edges and missing pieces. Additionally, approximately (b)(4) metal forming bars used to process caramel contained missing pieces. Your firm does not have a system to exclude metal particulates built into the manufacturing process.
Approximately (b)(4) plastic molds utilized for manufacturing Peppermint Snow Mints were missing pieces of material. These molds are (b)(4), and the product is subsequently packaged without further manufacturing.
Areas of missing paint on the (b)(4) machine over exposed Peanut Butter Americano dated 6/05/18. Furthermore, the plastic molds containing Peppermint Snow Mints lot #2147 was directly contacting a wall missing areas of paint. Also, missing areas of paint were found on the (b)(4) utilized to manufacture taffy and cream products.
We have received your response letter dated August 17, 2017, and find your response to be inadequate. You did not provide evidence that the observations have been corrected.
5) You failed to ensure that equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food are constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination as required by 21 CFR 110.80(b)(7). Specifically, (b)(4) was leaking from the pump, and the junction between the (b)(4) tank and the pump. The (b)(4) is utilized in the manufacture of Peppermint Snow Mints. The leaking pump area was an observation listed on the FDA 483 issued to you during the inspection ending on August 28, 2015.
Furthermore, based on labeling collected during the inspection of your firm, we note that several of your products are misbranded under section of 403 [21 U.S.C. § 343] of the Act and FDA’s labeling regulations under 21 CFR 101, as follows:
1) Your Cerreta’s Classics Golden Gourmet Caramel Corn with Premium Almonds and Arizona Pecans and Cerreta’s Candy Company White Pretzels are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], because the name of the manufacturer, city, state, and zip code are not applied to the labels.
2) Your Cerreta’s Classics Golden Gourmet Caramel Corn with Premium Almonds and Arizona Pecans are misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], because it does not include an ingredient statement required for multi-ingredient foods.
Your response to this letter should include updated labeling for these products as they were not provided in the response to the FDA 483. You are responsible for ensuring all product labeling complies with applicable regulations and the FD&C Act. Your response should also include a summary of the actions taken to ensure all distributed products are appropriately labeled.
In addition, we want to convey the following comment regarding your manufacturing operations:
1) Your firm must take all reasonable precautions to ensure production procedures do not contribute contamination from any source as required by 21 CFR 110.80. Your firm utilizes a variety of allergenic materials in the production including, but not limited to: milk, tree nuts, peanuts, and wheat. During the inspection, you explained to the Investigator that products containing various allergens may be manufactured on shared equipment. Without appropriate removal of allergenic proteins, this practice may cause cross contact between various products. Small amounts of allergenic proteins may cause harm to consumers. Your response to this letter should include a detailed plan as to how your firm plans to mitigate this potential issue.
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 and 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 enforcement regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
You should 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 corrections and/or corrective actions your firm has taken. If your firm’s planned corrections and/or 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) business days, state the reason for the delay and the time within which these activities will be completed.
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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs from the responsible party for the domestic facility.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Carolyn A. Pinney, Compliance Officer, PO Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Pinney at (303) 236-3024 if you have any questions about this matter.
Office of Human and Animal Food Operations-