The biggest issue was excessive insect activity, primary beetles, which were found throughout the facility. There was also some rodent poop. Along with this, as one would expect, was a lack of cleaning was also sited. This resulting excessive food material buildup is what the beetles are feeding on. There were some other GMP issues. Surprisingly, not much mention of the post-processing area where post-process contamination seems like it could be a huge Salmonella risk.
Also of note, this "facility meets the definition of a “qualified facility” under 21 CFR § 117.3; therefore, therefore not subject to having a food safety plan, and only "subject to the modified requirements in 21 CFR § 117.201 of the CGMP & PC rule.".
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/middle-eastsolis-baking-company-inc-dba-middle-east-baking-co-708017-07252025
Middle East/Soli's Baking Company, Inc. dba Middle East Baking Co.
MARCS-CMS 708017 — July 25, 2025
Recipient:
Mr. Isaac R. Cohen
Owner
Middle East/Soli's Baking Company, Inc. dba Middle East Baking Co.
1380 Marsten Rd
Burlingame, CA 94010-2406
United States
mideastsoli@gmail.com
Issuing Office:
Human Foods Program
United States
Mr. Isaac R. Cohen
Owner
Middle East/Soli's Baking Company, Inc. dba Middle East Baking Co.
1380 Marsten Rd
Burlingame, CA 94010-2406
United States
mideastsoli@gmail.com
Issuing Office:
Human Foods Program
United States
July 25, 2025
WARNING LETTER
Re: CMS #708017
Dear Mr. Cohen:
The United States Food and Drug Administration (FDA) inspected your pita manufacturing facility, located at 1380 Marsten Rd, Burlingame, CA 94010-2406, from November 20, 2024 to January 10, 2025. During our inspection of your facility, an FDA investigator 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). At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. During the inspection, the FDA investigator collected filth samples from various areas throughout your manufacturing facility and analysis found insect filth throughout the facility. You provided responses to the FDA-483 on January 17 and 24, 2025, describing corrective actions taken by your firm. Based on our review of the inspectional findings, analytical results, and responses that your firm has 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.
Based on FDA’s inspectional and analytical, we have determined that food, including pita and bagels 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.
Your significant violations of Current Good Manufacturing Practice (21 CFR Part 117, Subpart B) are as follows:
1. You did not take effective measures to exclude pests from the manufacturing, 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, during the inspection, on November 20, 21, and 25, 2024, apparent insects were observed throughout your manufacturing facility, including on and in all (b)(4) mixers, the pita dough divider, pita dough sheeter, pita dough proofer/conveyor, dishwashing area, bulk ingredient bins, near or on prep tables, and near the bulk flour silo.
North wall area:
a. On November 20, 2024, four dead apparent beetles and one live apparent beetle were observed on the leftmost “Sesame product only” mixer base, directly behind, and approximately (b)(4) inches from, the mixer bowl.
b. On November 20, 2024, two live apparent beetles were observed in the gearbox, which was approximately (b)(4) inches from and directly above, the mixing bowl of the third from the left mixer.
c. On November 20, 2024, three live apparent beetles were observed on the mixer base, directly behind the mixer bowl of the rightmost in-use mixer, approximately (b)(4) inches from mixer bowl.
d. On November 20, 2024, two live apparent beetles and one live apparent larva were observed in the gearbox, which was (b)(4) inches from and directly above the mixer bowl of the rightmost in-use mixer.
e. On November 20, 2024, two live apparent larvae were observed on the floor directly below the “(b)(4)”/leftmost mixer approximately (b)(4) inches from mixer bowl.
f. On November 20, 2024, two dead apparent beetles were observed on the floor directly below the second from the left mixer approximately (b)(4) inches from mixer bowl.
g. On November 21, 2024, one live apparent beetle and one dead apparent beetle were observed in a crack in the floor in front of the mixers approximately (b)(4) inches from mixers.
Northwest wall area:
h. On November 21, 2024, two live apparent white small jumping bugs were observed on the northwest wall with heavy apparent mold buildup directly behind bagel proofer and bagel oven approximately (b)(4) inches from back of product proofer.
i. On November 21, 2024, two live apparent beetles and two dead apparent beetles were observed on the floor behind pallets of flour and under stairs to employee breakroom/ingredient storage approximately (b)(4) inches from pallet holding raw ingredients.
j. On November 21, 2024, three live apparent beetles, one live apparent larva, one live apparent earwig were observed on the floor between the bagel proofer and bagel oven, approximately (b)(4) inches from front of product proofer.
North area:
k. On November 20, 2024, five live apparent beetles were observed in a box of tools directly below a prep table in front of the row of mixers approximately (b)(4) inches from prep tabletop.
l. On November 21, 2024, one live apparent beetle and two dead apparent beetles were observed on the rolling base underneath the leftmost ingredient bin approximately (b)(4) inches from bin lid.
m. On November 21, 2024, two live apparent beetles and two live apparent larvae were observed on the rolling base underneath the second from the leftmost ingredient bin approximately (b)(4) inches from bin lid.
n. On November 21, 2024, three live apparent larvae were observed on the rolling base underneath the third from the leftmost ingredient bin. Approximately (b)(4) inches from cracked bin lid.
o. On November 21, 2024, two live apparent beetles, two live apparent larvae, and two dead apparent beetles were observed on the rolling base underneath the rightmost ingredient bin approximately (b)(4) inches from the cracked bin lid.
Northeast wall area:
p. On November 20, 2024, four live apparent beetles and one dead apparent beetle were observed in the gearbox of an out of use mixer next to the mixers used to manufacture product approximately (b)(4) inches from mixer bowl holder.
Eastern wall area:
q. On November 20, 2024, two live apparent beetles were observed in the sesame disperser directly above pita sheeter line, which is approximately (b)(4) inches from product sheeter belts.
r. On November 21, 2024, two live apparent beetles, one live apparent larva were observed along the eastern wall of the manufacturing facility under the bottom belt of the pita proofing line approximately (b)(4) inches from product belt.
Northeast wall area:
s. On November 25, 2024, one live apparent larva, three live apparent beetles, and five dead apparent beetles were observed inside the pita dough divider/shaper machine just behind the panel and approximately (b)(4) inches from product shaping trays.
East corner area:
t. On November 21, 2024, two live apparent beetles, four live apparent larvae, and one dead apparent beetle were observed on the floor adjacent to a pallet of flour approximately (b)(4) inches from a pallet holding raw ingredients.
Center area:
u. On November 21, 2024, three live apparent beetles were observed on the floor underneath the prep table used to receive finished pitas from cooling conveyor approximately (b)(4) inches from prep tabletop in the finished product packing room.
v. On November 21, 2024, four live apparent beetles and three live apparent larvae were observed on the floor below pita (b)(4) conveyor at the entrance window to packing room approximately (b)(4) inches from cooling conveyance line.
w. On November 21, 2024, one live apparent larva and one dead apparent fly was observed on the floor below handwashing sink approximately (b)(4) inches from basin of handwashing sink in the dishwashing/handwashing area.
Southernmost area:
x. On November 21, 2024, five live apparent beetles, two live apparent larvae, one dead apparent larva, and three dead apparent beetles were observed by the base of flour silo approximately (b)(4) inches from silo sock in the flour silo room.
Southeast corner area of the manufacturing facility:
a. On November 21, 2024, one live apparent beetle, one live apparent larva, and one dead apparent beetle were observed on the floor next to an unused prep table storing ingredients approximately (b)(4) inches from prep tabletop.
Other Pest Exclusion Issues:
z. On November 20, 2024, between five ten apparent rodent excreta pellets were noted inside the gearbox of a mixer, approximately (b)(4) inches from the mixing bowl.
aa. Further, on November 20, 21, and 25, 2024, the backdoor to a covered outdoor area and the rollup doors at the front of the building next to barrels of water and a dumpster were left open during production while no deliveries or truck loading was occurring. Open doors may act as routes of entry for pests.
In addition, FDA collected sample 1269598 during the inspection, which was submitted to an FDA laboratory for analysis. This filth sample demonstrated insect activity throughout the facility and confirmed various species of insects at the larval, pupae, and adult stages.
We acknowledge that your January 24, 2025 response indicates that you are finalizing quotes with pest control for the insects found. However, this response is inadequate because it does not provide any details of the steps that will be taken to correct the insect findings and it provides no timeframe for correction. Your response does not address the rodent activity observed by the investigator.
2. You did not clean and sanitize your equipment in a manner and as frequently as necessary to protect against and contamination of food as required by 21 CFR § 117.35(a) and 21 CFR § 117.35(d). Specifically,
a. Your “(b)(4)” indicates that “(b)(4)” and that all machinery, including conveyor belts, mixers, belts, sheeters, ovens, and dividers are cleaned using only warm water and a towel. Your firm does not use detergent or a sanitizer to protect against contamination of food. Our investigator observed sanitation procedures on November 21 and 25, 2024 and confirmed that the firm only uses warm water to clean equipment and does not use any sanitizer or detergent for cleaning for food contact surfaces.
b. On November 20, 2024, the pita sheeter and pita proofer/conveyor fabric belts, which are food contact surfaces, had a build-up of apparent black mold. On November 25, 2024 “Trader Joe’s Whole Wheat Pita Bread” (Kwik lock lot code (b)(4)) were observed on the belts. In addition, a heavy buildup of apparent white and brown product residue remained on the fabric belts of this raw pita conveyance line after sanitation procedures had been completed on November 25, 2024.
c. On November 20, 2024, a heavy grey buildup of residue including apparent flour was noted on much of the observable pita (b)(4) conveyance line, which is a food contact surface for RTE pita, that encircles the manufacturing area. This was brought to the attention of firm management on November 20, 2024, who stated it was cleaned daily. However, on November 25, 2024, the heavy buildup was still observed during the production of “Trader Joe’s Whole Wheat Pita” (Kwik lock lot code (b)(4)).
d. During the inspection the dough divider machine, which is a food contact surface used for all pita products, was observed as having heavy white and brown buildup of apparent product residue along the dividers, brushes, and interior sides of the machine, after sanitation procedures had been completed on November 20, 21, and 25, 2024.
Your January 17, 2025 response indicates that you have incorporated soap into your sanitation program and that your mixers have been thoroughly cleaned including under the top covers to remove flour residue. Your response is inadequate because it does not fully address these cleaning and sanitizing violations. Further, you did not provide evidence of your stated corrective actions.
3. You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential contamination of food, as required by 21 CFR § 117.80(c)(2). Specifically:
a. During the inspection our investigator observed a heavy buildup of brownish-orange substance across the ceilings of the manufacturing area. During observation of production of the “Trader Joe’s Whole Wheat Pita Bread” on November 25, 2024, our investigator observed condensation from the ceiling dripping directly on to the (b)(4) conveyor carrying finished ready-to-eat product being conveyed to the packaging room to be packaged and distributed.
b. On November 25, 2024, our investigator observed flour falling off the pita dough divider/shaper being caught on pieces of cardboard and sheet pans that were placed directly on the production facility floor. An employee explained to our investigator that the flour is sieved and put back into the bulk flour bins.
c. Several belts were frayed along the pita production line. The frays ranged from approximately (b)(4) inch in length.
Your January 17 and January 24, 2025 responses did not address this observation.
4. You did not take reasonable measures and precautions to ensure that all persons working in direct contract with food, food-contact surfaces, and food packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR § 117.10(b). Specifically, on November 25, 2024:
a. Several employees, including the production supervisor, were observed touching the packaging room floor directly, then going back to handling ready-to-eat product that was being packaged without washing their hands.
b. Several employees, including the production supervisor, were observed touching the trays used to ship product and then going back to handling ready-to-eat product that was being packaged without washing their hands.
c. The production supervisor was observed on multiple occasions with his jacket sleeve that had apparent filth buildup on it, inside the finished product packaging while holding ready-to-eat product.
Your January 17 and January 24, 2025 responses did not address this observation.
5. You did not maintain your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR § 117.35(a). Specifically, the following were observed:
a. An extensive heavy buildup of apparent mold, black in color, was observed along the walls of the manufacturing area near the mixers, sheeters, proofers, along the entirety of the (b)(4) conveyance line, near raw ingredients, dishwashing area, and in the packaging room.
b. An extensive buildup of apparent flour was observed on the walls and floors, which was trapped within numerous cracks and crevices and was not removed after sanitation on November 20 or November 25, 2025. The buildup of apparent flour may act as a food source for pests.
Your January 24, 2025 response indicates that you are finalizing a quote with a painter to paint the entire interior of the building and that you will include photos once the job is complete. To date, we have not received any additional responses from your firm, so it is unclear if you have completed this corrective action. Further, the response does not address if or how the apparent mold will be addressed prior to painting.
You may find the Act and further information about the CGMP & PC rule through links in FDA's homepage at www.fda.gov.
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the cause of the violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations.
Re: CMS #708017
Dear Mr. Cohen:
The United States Food and Drug Administration (FDA) inspected your pita manufacturing facility, located at 1380 Marsten Rd, Burlingame, CA 94010-2406, from November 20, 2024 to January 10, 2025. During our inspection of your facility, an FDA investigator 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). At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. During the inspection, the FDA investigator collected filth samples from various areas throughout your manufacturing facility and analysis found insect filth throughout the facility. You provided responses to the FDA-483 on January 17 and 24, 2025, describing corrective actions taken by your firm. Based on our review of the inspectional findings, analytical results, and responses that your firm has 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.
Based on FDA’s inspectional and analytical, we have determined that food, including pita and bagels 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.
Your significant violations of Current Good Manufacturing Practice (21 CFR Part 117, Subpart B) are as follows:
1. You did not take effective measures to exclude pests from the manufacturing, 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, during the inspection, on November 20, 21, and 25, 2024, apparent insects were observed throughout your manufacturing facility, including on and in all (b)(4) mixers, the pita dough divider, pita dough sheeter, pita dough proofer/conveyor, dishwashing area, bulk ingredient bins, near or on prep tables, and near the bulk flour silo.
North wall area:
a. On November 20, 2024, four dead apparent beetles and one live apparent beetle were observed on the leftmost “Sesame product only” mixer base, directly behind, and approximately (b)(4) inches from, the mixer bowl.
b. On November 20, 2024, two live apparent beetles were observed in the gearbox, which was approximately (b)(4) inches from and directly above, the mixing bowl of the third from the left mixer.
c. On November 20, 2024, three live apparent beetles were observed on the mixer base, directly behind the mixer bowl of the rightmost in-use mixer, approximately (b)(4) inches from mixer bowl.
d. On November 20, 2024, two live apparent beetles and one live apparent larva were observed in the gearbox, which was (b)(4) inches from and directly above the mixer bowl of the rightmost in-use mixer.
e. On November 20, 2024, two live apparent larvae were observed on the floor directly below the “(b)(4)”/leftmost mixer approximately (b)(4) inches from mixer bowl.
f. On November 20, 2024, two dead apparent beetles were observed on the floor directly below the second from the left mixer approximately (b)(4) inches from mixer bowl.
g. On November 21, 2024, one live apparent beetle and one dead apparent beetle were observed in a crack in the floor in front of the mixers approximately (b)(4) inches from mixers.
Northwest wall area:
h. On November 21, 2024, two live apparent white small jumping bugs were observed on the northwest wall with heavy apparent mold buildup directly behind bagel proofer and bagel oven approximately (b)(4) inches from back of product proofer.
i. On November 21, 2024, two live apparent beetles and two dead apparent beetles were observed on the floor behind pallets of flour and under stairs to employee breakroom/ingredient storage approximately (b)(4) inches from pallet holding raw ingredients.
j. On November 21, 2024, three live apparent beetles, one live apparent larva, one live apparent earwig were observed on the floor between the bagel proofer and bagel oven, approximately (b)(4) inches from front of product proofer.
North area:
k. On November 20, 2024, five live apparent beetles were observed in a box of tools directly below a prep table in front of the row of mixers approximately (b)(4) inches from prep tabletop.
l. On November 21, 2024, one live apparent beetle and two dead apparent beetles were observed on the rolling base underneath the leftmost ingredient bin approximately (b)(4) inches from bin lid.
m. On November 21, 2024, two live apparent beetles and two live apparent larvae were observed on the rolling base underneath the second from the leftmost ingredient bin approximately (b)(4) inches from bin lid.
n. On November 21, 2024, three live apparent larvae were observed on the rolling base underneath the third from the leftmost ingredient bin. Approximately (b)(4) inches from cracked bin lid.
o. On November 21, 2024, two live apparent beetles, two live apparent larvae, and two dead apparent beetles were observed on the rolling base underneath the rightmost ingredient bin approximately (b)(4) inches from the cracked bin lid.
Northeast wall area:
p. On November 20, 2024, four live apparent beetles and one dead apparent beetle were observed in the gearbox of an out of use mixer next to the mixers used to manufacture product approximately (b)(4) inches from mixer bowl holder.
Eastern wall area:
q. On November 20, 2024, two live apparent beetles were observed in the sesame disperser directly above pita sheeter line, which is approximately (b)(4) inches from product sheeter belts.
r. On November 21, 2024, two live apparent beetles, one live apparent larva were observed along the eastern wall of the manufacturing facility under the bottom belt of the pita proofing line approximately (b)(4) inches from product belt.
Northeast wall area:
s. On November 25, 2024, one live apparent larva, three live apparent beetles, and five dead apparent beetles were observed inside the pita dough divider/shaper machine just behind the panel and approximately (b)(4) inches from product shaping trays.
East corner area:
t. On November 21, 2024, two live apparent beetles, four live apparent larvae, and one dead apparent beetle were observed on the floor adjacent to a pallet of flour approximately (b)(4) inches from a pallet holding raw ingredients.
Center area:
u. On November 21, 2024, three live apparent beetles were observed on the floor underneath the prep table used to receive finished pitas from cooling conveyor approximately (b)(4) inches from prep tabletop in the finished product packing room.
v. On November 21, 2024, four live apparent beetles and three live apparent larvae were observed on the floor below pita (b)(4) conveyor at the entrance window to packing room approximately (b)(4) inches from cooling conveyance line.
w. On November 21, 2024, one live apparent larva and one dead apparent fly was observed on the floor below handwashing sink approximately (b)(4) inches from basin of handwashing sink in the dishwashing/handwashing area.
Southernmost area:
x. On November 21, 2024, five live apparent beetles, two live apparent larvae, one dead apparent larva, and three dead apparent beetles were observed by the base of flour silo approximately (b)(4) inches from silo sock in the flour silo room.
Southeast corner area of the manufacturing facility:
a. On November 21, 2024, one live apparent beetle, one live apparent larva, and one dead apparent beetle were observed on the floor next to an unused prep table storing ingredients approximately (b)(4) inches from prep tabletop.
Other Pest Exclusion Issues:
z. On November 20, 2024, between five ten apparent rodent excreta pellets were noted inside the gearbox of a mixer, approximately (b)(4) inches from the mixing bowl.
aa. Further, on November 20, 21, and 25, 2024, the backdoor to a covered outdoor area and the rollup doors at the front of the building next to barrels of water and a dumpster were left open during production while no deliveries or truck loading was occurring. Open doors may act as routes of entry for pests.
In addition, FDA collected sample 1269598 during the inspection, which was submitted to an FDA laboratory for analysis. This filth sample demonstrated insect activity throughout the facility and confirmed various species of insects at the larval, pupae, and adult stages.
We acknowledge that your January 24, 2025 response indicates that you are finalizing quotes with pest control for the insects found. However, this response is inadequate because it does not provide any details of the steps that will be taken to correct the insect findings and it provides no timeframe for correction. Your response does not address the rodent activity observed by the investigator.
2. You did not clean and sanitize your equipment in a manner and as frequently as necessary to protect against and contamination of food as required by 21 CFR § 117.35(a) and 21 CFR § 117.35(d). Specifically,
a. Your “(b)(4)” indicates that “(b)(4)” and that all machinery, including conveyor belts, mixers, belts, sheeters, ovens, and dividers are cleaned using only warm water and a towel. Your firm does not use detergent or a sanitizer to protect against contamination of food. Our investigator observed sanitation procedures on November 21 and 25, 2024 and confirmed that the firm only uses warm water to clean equipment and does not use any sanitizer or detergent for cleaning for food contact surfaces.
b. On November 20, 2024, the pita sheeter and pita proofer/conveyor fabric belts, which are food contact surfaces, had a build-up of apparent black mold. On November 25, 2024 “Trader Joe’s Whole Wheat Pita Bread” (Kwik lock lot code (b)(4)) were observed on the belts. In addition, a heavy buildup of apparent white and brown product residue remained on the fabric belts of this raw pita conveyance line after sanitation procedures had been completed on November 25, 2024.
c. On November 20, 2024, a heavy grey buildup of residue including apparent flour was noted on much of the observable pita (b)(4) conveyance line, which is a food contact surface for RTE pita, that encircles the manufacturing area. This was brought to the attention of firm management on November 20, 2024, who stated it was cleaned daily. However, on November 25, 2024, the heavy buildup was still observed during the production of “Trader Joe’s Whole Wheat Pita” (Kwik lock lot code (b)(4)).
d. During the inspection the dough divider machine, which is a food contact surface used for all pita products, was observed as having heavy white and brown buildup of apparent product residue along the dividers, brushes, and interior sides of the machine, after sanitation procedures had been completed on November 20, 21, and 25, 2024.
Your January 17, 2025 response indicates that you have incorporated soap into your sanitation program and that your mixers have been thoroughly cleaned including under the top covers to remove flour residue. Your response is inadequate because it does not fully address these cleaning and sanitizing violations. Further, you did not provide evidence of your stated corrective actions.
3. You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential contamination of food, as required by 21 CFR § 117.80(c)(2). Specifically:
a. During the inspection our investigator observed a heavy buildup of brownish-orange substance across the ceilings of the manufacturing area. During observation of production of the “Trader Joe’s Whole Wheat Pita Bread” on November 25, 2024, our investigator observed condensation from the ceiling dripping directly on to the (b)(4) conveyor carrying finished ready-to-eat product being conveyed to the packaging room to be packaged and distributed.
b. On November 25, 2024, our investigator observed flour falling off the pita dough divider/shaper being caught on pieces of cardboard and sheet pans that were placed directly on the production facility floor. An employee explained to our investigator that the flour is sieved and put back into the bulk flour bins.
c. Several belts were frayed along the pita production line. The frays ranged from approximately (b)(4) inch in length.
Your January 17 and January 24, 2025 responses did not address this observation.
4. You did not take reasonable measures and precautions to ensure that all persons working in direct contract with food, food-contact surfaces, and food packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR § 117.10(b). Specifically, on November 25, 2024:
a. Several employees, including the production supervisor, were observed touching the packaging room floor directly, then going back to handling ready-to-eat product that was being packaged without washing their hands.
b. Several employees, including the production supervisor, were observed touching the trays used to ship product and then going back to handling ready-to-eat product that was being packaged without washing their hands.
c. The production supervisor was observed on multiple occasions with his jacket sleeve that had apparent filth buildup on it, inside the finished product packaging while holding ready-to-eat product.
Your January 17 and January 24, 2025 responses did not address this observation.
5. You did not maintain your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR § 117.35(a). Specifically, the following were observed:
a. An extensive heavy buildup of apparent mold, black in color, was observed along the walls of the manufacturing area near the mixers, sheeters, proofers, along the entirety of the (b)(4) conveyance line, near raw ingredients, dishwashing area, and in the packaging room.
b. An extensive buildup of apparent flour was observed on the walls and floors, which was trapped within numerous cracks and crevices and was not removed after sanitation on November 20 or November 25, 2025. The buildup of apparent flour may act as a food source for pests.
Your January 24, 2025 response indicates that you are finalizing a quote with a painter to paint the entire interior of the building and that you will include photos once the job is complete. To date, we have not received any additional responses from your firm, so it is unclear if you have completed this corrective action. Further, the response does not address if or how the apparent mold will be addressed prior to painting.
You may find the Act and further information about the CGMP & PC rule through links in FDA's homepage at www.fda.gov.
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the cause of the violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. 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:
Your facility meets the definition of a “qualified facility” under 21 CFR § 117.3; therefore, you are subject to the modified requirements in 21 CFR § 117.201 of the CGMP & PC rule. These modified requirements include the requirement that the facility submit a form to FDA, attesting to the facility’s status as a qualified facility. In addition, you must attest that you have identified potential hazards associated with the food being produced, are implementing preventive controls to address hazards associated with the food being produced and are monitoring the performance of the preventive controls to ensure that such controls are effective; or your facility is in compliance with State, local, or other non-Federal food safety law. To date, you have not submitted an attestation.
Please notify FDA in writing within fifteen (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 documents. If you cannot complete all corrections within fifteen (15) days, state the reason for the delay and the time frame 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 written response electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Kerry Kurdilla, Compliance Officer, at Kerry.Kurdilla@fda.hhs.gov. Please include reference CMS # 708017 on any submissions and within the subject line of any email correspondence to the agency. If you have questions regarding this letter, please contact Kerry Kurdilla, Compliance Officer, at Kerry.Kurdilla@fda.hhs.gov.
Sincerely,
/S/
Maria S. Knirk, JD MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Your facility meets the definition of a “qualified facility” under 21 CFR § 117.3; therefore, you are subject to the modified requirements in 21 CFR § 117.201 of the CGMP & PC rule. These modified requirements include the requirement that the facility submit a form to FDA, attesting to the facility’s status as a qualified facility. In addition, you must attest that you have identified potential hazards associated with the food being produced, are implementing preventive controls to address hazards associated with the food being produced and are monitoring the performance of the preventive controls to ensure that such controls are effective; or your facility is in compliance with State, local, or other non-Federal food safety law. To date, you have not submitted an attestation.
Please notify FDA in writing within fifteen (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 documents. If you cannot complete all corrections within fifteen (15) days, state the reason for the delay and the time frame 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 written response electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Kerry Kurdilla, Compliance Officer, at Kerry.Kurdilla@fda.hhs.gov. Please include reference CMS # 708017 on any submissions and within the subject line of any email correspondence to the agency. If you have questions regarding this letter, please contact Kerry Kurdilla, Compliance Officer, at Kerry.Kurdilla@fda.hhs.gov.
Sincerely,
/S/
Maria S. Knirk, JD MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
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