WARNING LETTER
RSV Pita, Inc. DBA Pita Pan Bakery
MARCS-CMS 719561 —
December 18, 2025
Delivery Method:
VIA ELECTRONIC DELIVERY
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Salomon Vidal
Recipient Title
Owner
RSV Pita, Inc. DBA Pita Pan Bakery
8602 NW 44th St
Lauderhill
,
FL
33351-6006
United States
solyvidal@icloud.com
Issuing Office:
Human Foods Program
United States
December 18, 2025
WARNING LETTER
Re: CMS # 719561
Dear Mr. Vidal:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) food manufacturing facility, located at 8602 NW 44th Street, Lauderhill, FL 33351-6006, from May 28, 2025 to June 11, 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).
Based on FDA’s inspectional findings, we have determined that food including pita, bagels, and challah, manufactured in your facility is 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. You may find the Act and further information about the CGMP & PC rule through links on FDA’s homepage at www.fda.gov.
Further, your Jerusalem Bagel, Sesame Pita Bread, and Challah Sesame Bread products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare the major food allergens, as required by section 403(w)(1) of the Act.
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. To date, we have not received a response to the FDA 483. After reviewing the inspectional findings, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.
Current Good Manufacturing Practice Requirements (21 CFR Part 117, Subpart B)
Your significant violations are as follows:
1. You did not clean and sanitize your equipment in a manner and as frequently as necessary to protect against allergen cross contact and contamination of food as required by 21 CFR 117.35(d). Specifically,
a. On May 29, 2025, your firm manufactured challah bread dough containing eggs on the mixer machine bowl, dough divider, and proofer. The same equipment was used to manufacture Jerusalem bagel dough that does not contain eggs without cleaning the shared food contact surfaces between the products. This practice does not protect your products from allergen cross contact.
b. On May 28 and May 29, 2025, the mixer machine was observed to be cleaned only with water and that the dough divider, pan sheeter machine, and the oven conveyor belt were not taken apart for cleaning. Cleaning consists of removing excess dough, and food residues with a brush and compressed air. On May 29, 2025, the oven conveyor belt, which was in direct contact with RTE pita, was encrusted with what appear to be old food residues between the metal links. On May 28, 2025, while manufacturing pita the left side of pan liner sheet of the pan sheeter machine had old, dry black food residues. The pan liner sheet was also torn and visibly damaged. The brushes used to clean the equipment were observed in disrepair and do not appear to be easily cleanable. These practices to not protect against contamination.
c. Your proofer cloth pan liners that are in direct contact with dough balls are not cleaned on a daily basis. On May 29, 2025, you manufactured challah bread dough containing eggs followed by Jerusalem bagel dough which contacted the cloth pan liners. This practice does not protect against allergen cross contact and contamination.
d. On May 29, 2025, one of your employees was observed washing and rinsing utensils at the three compartments sink and placed them to air dry without completing the
(b)(4)
step first. These utensils were previously used to apply the egg wash on the in-process challah bread.
2. You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for contamination of food, as required by 21 CFR 117.80(c)(2). Specifically:
a. On May 28, 2025 and May 29, 2025, dust and flour accumulation were observed encrusted on plastic curtains that divide the processing area from the retail area and on plastic curtains dividing the packaging area from the retail area. Employees were observed transporting uncovered RTE challah bread manufactured on May 29, 2025, which came into direct contact with the curtains located in the processing area and the packaging area.
b. On May 29, 2025 in the processing room, uncovered RTE pita bread was observed moving along the open oven conveyor belt passing adjacent to unshielded fluorescent light fixtures and an air conditioning vent. Both fixtures had visible dust and flour residue accumulation.
c. On May 28, 2025, uncovered in-process Jerusalem bagels with sesame seeds were stored underneath an unshielded light inside the walk-in-cooler.
d. In the packaging area, a rolling cart holding uncovered RTE challah bread that was manufactured on May 29, 2025, was observed directly being stored underneath damaged ceiling tile with watermarks and gaps in the tile.
e. During the
(b)(4)
of RTE pita bread that was manufactured on May 29, 2025, the back exit door was being held open with
(b)(4)
opened bags of flour placed directly on the floor. This practice does not protect against contamination of your raw material flour and entrance of pests.
3. You did not take reasonable measures and precautions to ensure that all persons working in direct contact 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, investigators observed multiple instances of poor hygienic practices including:
a. On May 29, 2025, during the packaging process of RTE challah bread, an employee was observed using their cell phone while handling and packaging RTE sesame challah bread first and then immediately proceeded to handle and package RTE challah bread without sesame seeds. The employee did not wash hands or change gloves in between handling these products with different allergen profiles or after handling their cellphone.
b. On May 28, 2025 and May 29, 2025, during the processing of RTE challah bread, Jerusalem bagels and pita bread, your employees did not wash their hands before donning and putting on gloves to start
(b)(4)
the RTE products. No hand washing was observed after touching their face and clothes, using their cell phones, and after performing cleaning activities before resuming hand contact with ready to eat foods.
c. On May 28, 2025 and May 29, 2025, male employees with facial hair were observed working with in-process and RTE products without wearing beard covers.
d. On May 28, 2025 and May 29, 2025, personal beverage bottles were observed stored on top and underneath preparation tables in processing areas. Additionally, one personal beverage bottle was stored inside the reach in freezer used to store frozen RTE pita bread and your employees were observed actively drinking water while working in the processing areas. Furthermore, a piece of bread for personal consumption was observed on top of a preparation table in the processing room.
e. On May 29, 2025, during the packaging of RTE pita bread, your employees were observed wearing torn gloves with holes on them while handling and packaging the RTE product.
f. On May 29, 2025, during the processing of challah bread dough, one of your employees was observed entering the processing room without a hair restraint.
4. Your plant equipment and utensils used in manufacturing and processing are not designed and of such material and workmanship as to be adequately cleanable, and adequately maintained to protect against contamination, as required by 21 CFR 117.40(a). Specifically, on May 28, 2025 and May 29, 2025 during the manufacturing of RTE challah breads, Jerusalem bagels, and pita bread investigators observed the following in the processing room:
a. Plywood trays were used to place in-process Challah breads and Jerusalem bagels at the end of the
(b)(4)
step. The interior surface of these trays was observed with food debris accumulation. In addition, wooden tables used to package ready to eat products were found with peeled paint, visible cracks, and grooves on it.
b. During
(b)(4)
that were observed attached with clear plastic tape. These
(b)(4)
with clear plastic tape cannot be easily cleaned and sanitized to protect against allergen cross-contact and contamination.
c. A spatula used to remove excess dough from food contact surfaces was observed with clear plastic tape on the handle and cannot be easily cleaned and sanitized.
d. The outer canvas flap at the exit point of the oven used to bake pita bread is frayed and burnt. This outer canvas flap was observed in direct contact with the RTE pita bread that was manufactured on May 29, 2025, while exiting the oven.
Misbranding Violations
Your Jerusalem Bagel, Sesame Pita Bread, and Challah Sesame Bread products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare the major food allergens, as required by section 403(w)(1) of the Act. Specifically, your Jerusalem Bagel product is manufactured using flour that contains wheat. Your Sesame Pita Bread and Challah Sesame Bread products are manufactured with sesame.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines “major food allergens” as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]: or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
The violations cited in this letter are 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 appears to meet the definition of a qualified facility
1
under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food rule (CGMP & PCHF rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117), subject to the modified requirements in 21 CFR 117.201. A qualified facility is required to submit an attestation to FDA that the facility is a qualified facility (21 CFR 117.201(a)(1)). In addition, a qualified facility is required by 21 CFR 117.201(a)(2) to submit one of the two following attestations to FDA:
An attestation that you have identified the potential hazards associated with the food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or
An attestation that the facility is in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries, including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State Department of Agriculture), or other evidence of oversight.
To date you have not submitted such 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 # 719561 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
_______________________
1
See definition of “qualified facility” in 21 CFR 117.3.
Content current as of:
05/05/2026
Regulated Product(s)
Food & Beverages