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Cafe Valley Bakery, LLC MARCS-CMS 603875 —

Delivery Method:
Food & Beverages

Recipient Name
Brian Owens
Recipient Title
Cafe Valley Bakery, LLC

7000 W. Buckeye Road
Phoenix, AZ 85043
United States

Issuing Office:
Office of Human & Animal Food Operations East 6

United States


March 18, 2020

Dear Mr. Owens:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) bakery manufacturing facility located at 3701 S. Adams St., Marion, IN 46953, from November 5, 2019, through December 17, 2019. 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). Additionally, 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, including the same strains found during FDA inspections in 2018 and 2016. FDA’s inspection resulted in issuance of an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. Based on FDA’s inspectional findings and the analytical results for the environmental samples, we determined the bakery 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 firm’s written response to the FDA-483 on January 6, 2020, describing corrective actions taken and planned by your firm. After reviewing the inspectional findings and responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

Hazard Analysis and Risk-Based Preventive Controls (Subpart C):

You are required to identify and 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 your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)), as required by 21 CFR 117.135(a)(1). In your food safety plan, you identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate resident strains of L. monocytogenes in your facility, you did not 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 laboratory analysis of the environmental sample INV1116964 collected on November 5, 2019, during the production of RTE croissants confirmed nineteen (19) of seventy-six (76) environmental swabs collected tested positive for L. monocytogenes. Of the positive findings, two swabs were collected from (b)(4) that transport unpackaged RTE croissants from a (b)(4) to packaging. The remaining swabs were collected from various non-food contact surfaces, including inside the croissant (b)(4), the floor underneath the croissant production line, the muffin (b)(4), underneath the muffin (b)(4) from the (b)(4), the floor in the cake (b)(4), and the wheel on a (b)(4) cart used throughout your facility.

In addition, L. monocytogenes was found in environmental samples collected at your facility during FDA inspections in 2016 and 2018. In 2016, L. monocytogenes was found in five environmental swabs of the floors and drains. In 2018, L. monocytogenes was found in three environmental swabs of the floors and drains. The microbiological strains of L. monocytogenes were isolated from the environmental swabs. In general, one strain was isolated from each sample. However, two different strains of L. monocytogenes were identified in one subsample from 2016.

Whole genome sequencing (WGS) was conducted on the nineteen (19) L. monocytogenes isolates obtained from the 2019 FDA environmental samples, six (6) L. monocytogenes isolates obtained from the 2016 environmental samples, and three (3) L. monocytogenes isolates obtained from the 2018 environmental samples. By inference of the evolutionary relationships, the analysis of WGS data from bacterial human pathogens enables high resolution comparison between isolates. The current WGS analysis determined that the isolates derived from the samples collected at your facility during the three inspections represent three (3) strains of L. monocytogenes, and two of the three strains appear to have been present in your facility since 2016.
- One strain of L. monocytogenes was identified in five (5) isolates from the 2016 inspection, one isolate from the 2018 inspection, and nine isolates from the 2019 inspection.
- A second strain of L. monocytogenes was identified in one (1) isolate from 2016, one isolate from 2018, and four isolates from 2019.
- A third strain of L. monocytogenes was found in one isolate from 2018 and six (6) isolates from 2019. We notified you of the WGS results via conference call on January 9, 2020.

The presence of the same strains of L. monocytogenes over multiple years indicates there have been multiple resident pathogens in your facility since 2016. We advised you of those WGS results via a conference call on January 9, 2020.

The reoccurring presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are 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 grow 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.

We acknowledge you voluntarily destroyed all croissant products produced between the cleaning performed before and after our environmental samples were taken. In addition, your written response outlines the corrective actions you plan to take and those you have implemented, including hiring a third party (b)(4) company to (b)(4) with (b)(4), retraining sanitation employees, switching sanitizing chemicals used for (b)(4) of the (b)(4), increasing the concentration of (b)(4) used in your “(b)(4)” process, increasing the (b)(4) concentration in your foot baths, (b)(4) and (b)(4) floor cleaning tools, increasing environmental swabbing from (b)(4) swabs a (b)(4) to (b)(4) swabs a (b)(4), employee traffic areas and areas around the floor and feet of product (b)(4), and addressing (b)(4) within the (b)(4) of the croissant (b)(4) and along the croissant (b)(4).

In addition, we are aware that your initial environmental sample data from your (b)(4) environmental monitoring program in December 2019 did not detect the presence of Listeria in your facility. However, in light of the history of FDA’s findings of L. monocytogenes in your facility, effective environmental sampling conducted as verification of corrective actions should follow a comprehensive and extensive survey of your facility that includes samples collected several hours into production in greater quantity and locations than were taken in your (b)(4) monitoring program. Furthermore, we encourage you to continue to evaluate your facility to ensure you have identified all areas where L. monocytogenes is likely to be found. We remind you that environmental sampling is most effective at identifying pathogens when extensive sampling occurs several hours into production, because production activities may dislodge pathogens from harborage sites. You should continue to implement the necessary methods and controls to ensure foodborne pathogens do not contaminate your RTE food products. Your record keeping will be critical to demonstrate your implementation of these corrections consistently over time. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.

Current Good Manufacturing Practice (Subpart B):

1. Your firm did not conduct operations in accordance with adequate sanitation principles nor take adequate precautions to ensure that production procedures did not contribute to contamination, as required by 21 CFR 117.80(a)(1) and (4). Specifically,

• Your firm was running (b)(4) production on the croissant line without performing a full production line cleaning with (b)(4) for approximately (b)(4). (b)(4) production runs without sanitation increases the probability of pathogens surviving in the environment and contaminating product. A similar observation was made during the 2018 inspection.

• Wheeled production carts were observed being used throughout the facility without being cleaned and sanitized before moving to different areas of production. FDA recovered an L. monocytogenes positive environmental swab from the wheel of one of the carts used in production.

• Throughout the inspection, employees were observed moving in between different areas and stages of production, such as the raw material production and finished product packaging, without taking any measures to prevent cross-contamination, such as changing outer garments and using foot baths containing sanitizer.

Before the conclusion of the inspection, you stated that you were going to reduce your production runs to (b)(4) and implement a sanitation procedure for (b)(4) cleaning of packaging food contact surfaces during (b)(4) production. Further, your response states you have changed your employee traffic patterns, imposed movement restrictions and created traffic patterns that cause employees to make use of foot baths, limited foot traffic in areas surrounding your production sanitation washroom, and segregated equipment from employee walkways. In addition, you state that you have (b)(4) and are monitoring the sanitizer concentration (b)(4) in the foot baths. We will evaluate and verify the adequacy of your corrective actions during the next inspection.

2. Your plant was not constructed and designed to facilitate maintenance and sanitary operations and permit taking of adequate precautions to reduce the potential for contamination of food contact surfaces, as required by 21 CFR 117.20(b) and(b)(2). On December 13, 2019, our investigators observed the accumulation of (b)(4) within the (b)(4) of the croissant line and along the (b)(4) directly above the croissant (b)(4) from the (b)(4). This area of production is just prior to packaging of the RTE croissants. Swabs collected from the (b)(4) at the croissant (b)(4) tested positive for L. monocytogenes.

You state that you corrected the (b)(4) issue by installing a (b)(4) in the (b)(4) to(b)(4) away from finished product and food contact surfaces.

3. You did not keep buildings, fixtures, and other physical facilities in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). On December 13, 2019, our investigators observed the food contact surface of the (b)(4) on your croissant line (b)(4) and touching (b)(4). This (b)(4) is located post baking and before the (b)(4) for the croissant line where (b)(4) were observed.

Your response states that you (b)(4), so the (b)(4). However, you did not show that you will routinely check the (b)(4) to ensure the condition does not reoccur. We will verify the adequacy of your corrective actions during the next inspection.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the cause of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that you comply with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

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 reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31 (a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 FD&C Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

You should respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future. Your response should include any documentation necessary that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

Your firm’s response should be sent to, Dr. Byron Ho, DVM, Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Dr. Byron Ho at (313) 393-8262 or via email byron.ho@fda.hhs.gov.


William R. Weissinger, MS
Chicago District Director
Office of Human and Animal Food Operations
Division East 6



Paul D. Dash, General Manager
Café Valley Bakery, LLC
3701 S. Adams St.
Marion, IN 46953

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