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WARNING LETTER

Marin Baking LLC MARCS-CMS 700600 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Farid M. Radwan, Co-owner
Recipient Title
Michael D. Humphrey, Co-owner
Marin Baking LLC

1512 4th Street
San Rafael, CA 94901
United States

Issuing Office:
Human Foods Program

United States

WARNING LETTER

May 28, 2025

Reference: CMS Case # 700600

Dear Messrs. Radwan and Humphrey:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) bread product manufacturing facility, located at 1512 4th Street, San Rafael, CA, from November 14 through November 26, 2024. During our inspection of your facility, FDA investigators found significant 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 the inspection, FDA collected filth samples from various areas within your manufacturing facility, and the analytical results revealed rodent excreta pellets and multi-stage beetles (adult and larva).

Based on FDA’s inspectional and analytical findings, we have determined the RTE bread products processed 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 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 FDA’s regulations through links on FDA’s website at www.fda.gov.

At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA 483), Inspectional Observations. We received your written response, dated December 12, 2024, describing corrective actions planned by your facility. After reviewing the inspectional findings and response 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. We address your response below.

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

1. Your written allergen preventive controls did not include procedures, practices, and processes for ensuring protection of food from allergen cross-contact, including during storage, handling, and use; and for food labeling to ensure the food is not misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(c)(2). Specifically:

a. Your facility’s written hazard analysis determined that “allergens” are a hazard requiring a preventive control at the (b)(4) steps for “All Dough Types” (in-process food) and at the (b)(4) steps for “All Bread Types” (finished product). Your facility manufactures a variety of bread products with unique allergens (such as sesame) on shared food-contact equipment and on the same production day. Your Food Safety Plan document indicates that the hazard of allergen cross-contact will be significantly minimized or prevented through employee hygiene practices and cleaning/sanitizing of “work surfaces” such as tables, mixers, divider/molder, and pans/racks. However, the “SANITATION PREVENTIVE CONTROLS” section of your Food Safety Plan did not address control of allergen cross-contact for shared food-contact equipment at the (b)(4) step for the finished product. Furthermore, your written corrective action procedures for your allergen controls did not include steps to evaluate all affected food for safety and prevent all affected food from entering commerce if you cannot ensure food is not adulterated (see 21 CFR 117.150(a)(2)).

In addition, your sanitation procedures were not completely followed. Your “SANITATION PREVENTIVE CONTROLS” section of your Food Safety Plan for the (b)(4) steps indicates regular cleaning and sanitizing of “(b)(4)” will occur between “(b)(4).” However, sanitation only occurs once (b)(4) day at the end of production and not all shared food-contact equipment is included in your daily sanitation. For example, your wire racks used for (b)(4) are cleaned every (b)(4) months. In addition, the list of equipment in your “SANITATION SCHEDULE” document does not include all shared food-contact equipment. For example, (b)(4).

We note that you did not have adequate controls in place for allergen cross-contact, as evidenced by the following observations during the inspection on November 19, 2024:

i. Sesame seeds were observed on the food-contact surfaces of baking trays holding exposed Sweet Longie bread, which does not contain sesame seeds as an ingredient. In addition, at least two loaves of the Sweet Longie bread appeared to have sesame seeds baked onto the outer surface of the loaf.

ii. Sesame seeds were observed on the food-contact surfaces of baking trays holding exposed Ciabatta bread, which does not contain sesame seeds as an ingredient. In addition, at least one roll of Ciabatta bread appeared to have sesame seeds baked onto the outer surface of the roll.

Your facility placed the Sweet Longie and Ciabatta breads exposed to sesame seeds into food waste containers for disposal on November 19, 2024.

Your response indicated you will develop “(b)(4)”; implement monitoring, verification, and corrective actions; “(b)(4)”; maintain “(b)(4)”; and use a (b)(4) system to “(b)(4).” However, we cannot assess the adequacy of your stated corrective actions because you have not provided supporting documentation, such as sanitation procedures and implementation records.

b. Your facility’s written hazard analysis determined that “allergens” are a hazard requiring a preventive control at the (b)(4) step for “(b)(4)” (finished product). Your facility manufactures a variety of RTE bread products that contain allergens (such as wheat, milk, and sesame). Your “FOOD ALLERGEN PREVENTIVE CONTROLS” section of your Food Safety Plan states, “(b)(4).” However, your “FOOD ALLERGEN PREVENTIVE CONTROLS” later indicates these procedures are only required at the (b)(4) step for raw materials to “(b)(4)” (e.g., “(b)(4)”). Although your procedures address labelling of ingredient storage bins, your allergen controls did not include procedures to properly identify undeclared allergens and ensure the correct label is applied to the correct finished product. Your RTE breads are packaged in clear plastic bags, and you did not have procedures in place to ensure labels are affixed to the packaging with the correct major food allergens stated. Therefore, your Food Safety Plan did not include preventive controls to ensure that all food allergens are included on the finished product label (see 21 CFR 117.135(c)(2)(ii)).

We note that you did not have adequate controls in place for undeclared allergens. We observed during our inspection that most of your bread products (such as Sesame Seeded Hot Dog Rolls) are packaged in unlabeled plastic bags and then the bags are placed into unlabeled cardboard cases or on plastic bakery trays for distribution.

Your response indicated you will establish “(b)(4)” and regularly audit “(b)(4).” However, we cannot assess the adequacy of your stated corrective actions because you have not provided supporting documentation, such as labeling procedures and implementation records.

2. You did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control for your RTE bread products, as required by 21 CFR 117.130(a)(1). Specifically, your facility’s written hazard analysis did not consider recontamination with environmental pathogens, such as Salmonella, at all steps where your RTE bread products are exposed to the environment. Though your hazard analysis determined that “(b)(4)” are a hazard requiring a preventive control at the (b)(4) steps for “(b)(4)” (finished product), it did not consider recontamination with environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard at the (b)(4) step. Your facility manufactures RTE bread products (such as RTE Sliced Sourdough bread) which are exposed to the environment after baking and handled by employees prior to being packaged, such as during the (b)(4) step. 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 pathogens. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard.

Furthermore, environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)). You were not performing environmental monitoring to evaluate the effectiveness of your sanitation practices.

In addition, you did not follow your (b)(4) sanitation procedures. Your “SANITATION PREVENTIVE CONTROLS” section of your Food Safety Plan indicates (b)(4).” Your verification procedure states that the “(b)(4).” However:

i. Your facility’s General Manager indicated that food-contact surfaces on the large and small slicer are not sanitized. Your “SANITATION SCHEDULE” indicates (b)(4).
ii. Your facility’s General Manager indicated that wire racks are cleaned with water and detergent every (b)(4) months and the tables are wiped down daily with a cloth, but these food-contact surfaces are not sanitized. Additionally, frequency of cleaning for your tables and wire racks was missing from your “SANITATION SCHEDULE.”
iii. You manufacture (b)(4) days per week and your “SANITATION SCHEDULE” indicates equipment (e.g., (b)(4)) are cleaned/sanitized (b)(4) days per week. However, your employee responsible for monitoring the sanitation process is only present at the facility (b)(4) days per week. Therefore, monitoring is not performed (b)(4) out of the (b)(4) manufacturing days at your facility each week.

Furthermore, preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR 117.140). We note that you did not have adequate controls in place for contamination with environmental pathogens regarding sanitation, monitoring, and verification activities, as evidenced by the following observations during the inspection on November 19, 2024:

i. Your large slicer was observed to have an accumulation of apparent caked-on food residue or debris on multiple food-contact surfaces prior to and during use for slicing of RTE Sliced Sourdough bread.
ii. Your small slicer was observed to have an accumulation of apparent caked-on food residue or debris on food-contact surfaces on the inside of the slicer prior to use for cutting RTE Sesame Seeded Hot Dog Rolls.
iii. Your wire racks holding RTE bread, such as Sourdough and Whole Wheat loaves, were observed to have an accumulation of apparent caked-on food residue or debris on the food-contact surfaces.

Your response indicated you will develop “(b)(4)”; implement monitoring, verification, and corrective actions; “(b)(4)”; maintain “(b)(4)”; and establish environmental monitoring. However, we cannot assess the adequacy of your stated corrective actions because you have not provided documentation, such as your sanitation procedures and monitoring records. We will assess the adequacy and implementation of your corrective actions during a future inspection.

Current Good Manufacturing Practice Requirements (21 CFR Part 117, Subpart B):

1. You did not clean your non-food-contact surfaces of equipment used in the operation of a food plant in a manner and as frequently as necessary to protect against contamination of food, food-contact surfaces and food packaging materials, as required per 21 CFR 117.35(e). Specifically, on November 20, 2024, a dark-colored buildup of apparent filth was observed directly above ice on the interior of your ice machine. Ice from this ice machine is used in the production of dough such as for the RTE Sourdough Longie bread.

2. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 117.35(c). Specifically:

a. Rodent activity:
i. On November 19, 2024, too numerous to count rodent excreta pellets (REPs) were observed on a dry ingredient storage shelf located against a wall in the cooling and packaging area of the production facility. This storage shelf contained bags of dry ingredients (such as sesame seeds, calcium propionate, rolled oats, and corn meal) and (b)(4) bags were observed to have apparent rodent gnaw holes. RTE loaves of Sourdough bread were cooling on a rack approximately (b)(4) from this dry ingredient storage shelf.

ii. On November 19, 2024, 1 REP was observed on the floor adjacent to the three-compartment sink located in the mixing room, and 1 REP was observed on the floor underneath the same three-compartment sink. Dutch Crunch dough was glazed approximately (b)(4) feet from this three-compartment sink.

iii. On November 19, 2024, 1 REP was observed on the floor along the (b)(4) facing wall of the production facility. Containers used to hold food waste were located approximately (b)(4) feet from where the REP was observed.

iv. On November 19, 2024, 2 REPs were observed on top of cardboard boxes holding plastic bags used to package RTE “SOUR SLICED FRENCH” and RTE “EUROPEAN STYLE WHEAT” bread. These boxes were stored against the wall behind ovens (b)(4), which was approximately (b)(4) feet from the slicing machine where an employee was slicing RTE Sourdough bread.

v. On November 20, 2024, 1 REP was observed on the floor in the mixing room approximately (b)(4) inches away from the Erika Record Rounder and approximately (b)(4) inches from the wooden tabletop used during production.

vi. On November 20, 2024, 2 REPs were observed on the floor next to the walkway leading down to the flour silo and approximately (b)(4) inches from a metal shelf holding brown paper bags.

vii. On November 20, 2024, 1 REP was observed on a cardboard surface approximately (b)(4) feet from the flour silo.

viii. On November 20, 2024, 1 REP was observed on the floor approximately (b)(4) feet from an ice machine containing ice used in the production of dough such as for the RTE Sourdough Longie bread.

b. Insect activity:
i. On November 19, 2024, 1 dead insect was observed in the mixing room on top of a stainless-steel table used to measure ingredients such as butter flavor. A container of butter flavor ingredient was located approximately (b)(4) feet away.
ii. On November 19, 2024, 1 dead insect was observed in the mixing room on the floor adjacent to the three-compartment sink. Dutch Crunch dough was glazed approximately (b)(4) feet from this three-compartment sink.

iii. On November 20, 2024, 1 live insect larva was observed in the mixing room inside an electrical panel on the back of an unused mixer. This mixer was approximately (b)(4) feet from a wooden tabletop used during production.

iv. On November 20, 2024, 1 live insect was observed on a blue plastic bag located approximately (b)(4) from the flour silo.

c. FDA collected several samples for filth during our inspection from within your manufacturing facility locations noted above (samples 1277727 and 1277728). These samples were submitted to FDA labs for analysis. These samples resulted in numerous filth findings including the presence of rodent excreta pellets of a size implicating rat or mouse excreta pellets and multi-stage beetles (adult and larvae). The filth samples further demonstrate the presence of rodents and insect activity throughout the facility through the presence of rodent hairs and in pellet morphology as well as confirmation of various species of insects at larval and adult stages.

d. On November 14, 2024, a gap of approximately (b)(4) was observed below the (b)(4) emergency exit door.

e. During the inspection, your (b)(4) door into the cooling and packaging area was observed to be left open at multiple points throughout the day.

Your facility placed the bags of dry ingredients with apparent rodent gnaw holes into food waste containers for disposal on November 19, 2024.

Your response indicated you (b)(4). However, we cannot assess the adequacy of your stated corrective actions because you have not provided documentation, such as your pest control records, showing implementation of the proposed corrective actions. We will assess the adequacy and implementation of your corrective actions during a future inspection.

The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist at your facility or in connection with your products. 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 applicable 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 by the FDA 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:

  • We note that each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility, and the individual’s assigned duties, as required by 21 CFR 117.4(b)(2). You are required to establish and maintain documentation of this training for each individual, as provided by 21 CFR 117.4(d).

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.

Please send your reply to the Food and Drug Administration, Attention: Carrie Jolly, Compliance Officer, via email at carrie.jolly@fda.hhs.gov. If you have any questions regarding this letter, you may contact Carrie Jolly, Compliance Officer, via email at carrie.jolly@fda.hhs.gov. Please reference 700600 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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