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WARNING LETTER

Tropical Bakery Wholesale MARCS-CMS 598858 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
20-HAFE4-WL-05
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Harold Mir
Recipient Title
President
Tropical Bakery Wholesale

2460 West 1st Avenue
Hialeah, FL 33010-1718
United States

Issuing Office:
Division of Human and Animal Food Operations East IV

United States


February 26, 2020

WARNING LETTER

20-HAFE4-WL-05/CMS No. 598858

Dear Mr. Mir:

The United States Food and Drug Administration (FDA) inspected your manufacturing facility located at 2460 West 1st Avenue in Hialeah, Florida on September 9-12, 23, and 26, 2019, where you manufacture ready-to-eat (RTE) baked and frozen breads and pastries. The inspection revealed 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 to you a Form FDA-483, Inspectional Observations listing the deviations found at your facility. Based on FDA’s inspectional findings, we have determined that your bakery products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(a)(4)] because 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. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control’s 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 can find the Act and applicable regulations through links in FDA’s Internet homepage at www.fda.gov.

Additionally, as a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, your facility is subject to the registration requirements set forth in § 415 of the Act, [21 U.S.C. § 350d] and our implementing regulation at 21 CFR Part 1, Subpart H. You were advised of this requirement during previous FDA inspections and during the inspection referred above. Failure to register a facility as required, is a prohibited act under §301(dd) of the Act, 21 U.S.C. § 331(dd). (b)(3).

We received your firm’s response to the FDA-483 on October 18, 2019, which included a written description of your corrective actions. 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):

1. You did not prepare, or have prepared, and did not implement a food safety plan for the food products manufactured in your facility, as required by 21 CFR §117.126. A food safety plan must include the following:

(1) The written hazard analysis, as required by § 117.130(a)(2);
(2) The written preventive controls, as required by § 117.135(b);
(3) The written supply-chain program, as required by subpart G;
(4) The written recall plan, as required by § 117.139(a);
(5) The written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a);
(6) The written corrective action procedures, as required by § 117.150(a)(1); and
(7) The written verification procedures, as required by § 117.165(b).

Your response states you are “working on getting a written food safety plan.” You have not provided information that these corrective actions have been completed nor did you provide any timelines for completion of the food safety plan. We note that you have been required to comply with the preventive controls requirements in the CGMP & PC rule since September 18, 2017.

2. You did not conduct a hazard analysis for any of your products. In particular, you did not identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a). Specifically,

a. You did not identify undeclared allergens due to incorrect labeling or allergen cross-contact as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. Your facility manufactures multiple products that contain allergens, such as milk, eggs, soy, and wheat, which must be declared on the label. In addition, your facility manufactures multiple products with different allergen profiles on shared equipment.

b. You did not evaluate biological hazards such as Clostridium botulinum, pathogenic Escherichia coli, Salmonella, and/or Staphylococcus aureus as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. Your facility manufactures products with wheat flour, cheese, and eggs that have been known as a common source of biological hazards.

c. You did not evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, as a known or reasonably foreseeable hazard to determine whether environmental pathogens are a hazard requiring a preventive control. Your facility manufactures RTE food (bread, croissants, pastries, rolls, hamburger buns) which are exposed to the environment prior to packaging and after the food undergoes a (b)(4). The packaged baked product does not receive (b)(4) that will significantly minimize pathogens after packaging.

d. You did not evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether mycotoxins are a hazard requiring a preventive control. Your facility manufactures multiple products with wheat flour. This ingredient has been associated with mycotoxins.

Your response states you are “working on getting a Hazard analysis system for [your] company.” Your response also stated you cleaned all equipment, ordered new conveyor belts, implemented a different cleaning process for the pastry line, and provided employee training. However, you have not provided information that these corrective actions have been completed. We are unable to fully evaluate the adequacy of these corrections because you did not provide any details regarding the steps you have taken or will take, specifically regarding your promised systems, processes, procedures or employee training, nor did you provide additional documentation or evidence to demonstrate what these activities will entail.

Current Good Manufacturing Practice (Subpart B):

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

a. Throughout the inspection, live flies, too numerous to count, were observed in all processing areas. Flies were seen on raw materials, (b)(4) product, food contact equipment and utensils, and RTE baked breads and pastries, including shaped dough ready for baking, cooked uncovered bread and pastries. Additionally, an open container of vegetable oil which is applied directly to pre-baked bread dough during the (b)(4) process was observed to have approximately (b)(4) dead flies inside. During our previous inspections of your facility, similar observations involving flies in or on your food were made.

b. A live bird was observed inside of the dry storage area where the raw material foods and racks with baking trays used for the loaves of bread are stored. Similar observations were made during our previous inspections.

c. A live roach was observed in between the (b)(4) working (b)(4) mixers in the (b)(4) manufacturing room. A live roach was also observed in the employee bathroom opposite the (b)(4) cooler that is out of service. (b)(4) live roaches were observed crawling along the wall directly adjacent to the (b)(4) table where an employee paints egg wash on the pastries. The (b)(4) table is positioned directly against the wall and often has exposed trays of food on top. All finished product comes into this area to be processed (e.g., (b)(4)) and/or packaged. Similar observations were made during our previous inspections.

d. Throughout the entirety of the inspection, the (b)(4) door leading to the (b)(4) area was kept open without screening. In addition, the bay door directly in front of the retail area and manufacturing ovens was kept open during production. The screening near the (b)(4) area had holes such that it was not adequate to prevent the entry of pests. Similar observations were made during our previous inspections.

e. There were pallets, packaging material, old equipment and other general clutter on the outside of the facility near the entrances. These areas could serve as potential harborage for pests. Similar observations were made during our previous inspections.

In your response you stated that you installed (b)(4) curtains on all doors, cleaned and cleared all areas of general debris, and notified your pest control company of the roaches. You provided (b)(4) photographs showing (b)(4) curtains across exterior doorways completely open to the outside; however, you did not describe the location of these openings or their proximity to the production areas where the flies were observed by our investigators. You also did not provide any evidence to document that the other corrections had been achieved. If you have fully implemented these corrections, you may provide documentation of such with your response to this letter. If you have not implemented all corrections, please provide a timeline as to when these corrections will be fully implemented. We will evaluate and verify the adequacy of your corrective actions during our next inspection.

2. You did not clean and sanitize your utensils or equipment as frequently as necessary to protect against allergen cross-contact and contamination of food as required by 21 CFR 117.35(d). Throughout the inspection, our investigators observed unclean utensils and equipment used to manufacture bread and pastries, some but not all which contain the allergens milk, egg, or soy. You also did not have any written sanitation procedures for the cleaning of food contact equipment and surfaces. These practices and conditions create the potential for either allergen cross contamination from leftover food material containing the allergens milk, egg or soy to products which do not contain these allergens or for contamination of your products from leftover food material which can support the growth of microorganisms, including human pathogens. Specifically,

a. Baking trays used interchangeably for all of your RTE products, including those with cheese, were heavily encrusted with baked-on food residue on the food contact surfaces. You stated that the trays are never cleaned. Similar observations were made during a previous inspection.

b. (b)(4) manufacturing equipment was seen with heavy buildup of food residue on the food contact surfaces. As dough passes through (b)(4), it may contact this food debris. Heavy buildup of old food residue was also observed on non-food contact surfaces that employees manipulate during processing such as the controls, levers, and buttons. Similar observations were made during our previous inspections.

c. In the (b)(4) manufacturing room, cheese filling from the extruder spout came in direct contact with a food contact surface conveyor belt used to produce a variety of pastries, some of which do not include cheese as an ingredient or contain the allergen, milk. You confirmed that the cleaning process for this line is conducted using only pressurized air without wet cleaning, creating the potential for allergen cross contact on this line.

d. Several conveyor belts, including on the pastry manufacturing line, that come in direct contact with food items during processing of the lines throughout the facility were soiled and discolored.

e. A large (b)(4) bin used to hold (b)(4) flour in the (b)(4) manufacturing area had a heavy buildup of encrusted food residue on food contact and exterior surfaces. Similar observations were made during a previous inspection.

f. The walls and work tables were wiped solely with undiluted bleach.

g. The food contact surfaces of clean-in-place equipment was washed with detergent and water but not sanitized. Similar observations were made during our previous inspections.

3. You did not conduct all food holding under such conditions and controls as are necessary to minimize the potential for allergen cross-contact, contamination of food, and deterioration of food, as required by 21 CFR 117.80(c)(2). Specifically,

a. Bread was stored uncovered on moveable racks under water-damaged ceiling tiles, some with leaking condensate dripping from the ceiling directly onto the racks and bread stored beneath. Additionally, (b)(4) bread dough and bread and pastries were stored exposed on racks with flaking and chipping paint or rust directly above. Similar observations were made during our previous inspections.

b. A (b)(4) can with motor oil and an (b)(4) oil filter were observed on top of bags of flour used for the manufacturing of baked goods. The oil was observed to have soaked into the fabric of the bag, potentially contaminating the raw material stored within. Similar observations were made during our previous inspections.

c. RTE (b)(4) bread was seen directly contacting a trash bin while your employee was maneuvering the rack on which the loaf was stored. Similar observations were made during our previous inspections.

d. A (b)(4) rolling pin in the (b)(4) manufacturing room was seen stored with the handle end that employees contact with their hands embedded in a bin filled with flour. Another rolling pin was seen leaning against equipment with the handle directly on the floor. Similar observations were made during our previous inspections.

In your response you indicated that you replaced all ceiling tiles and painted the ceiling that was rusted. You provided (b)(4) photograph of (b)(4) intact ceiling tiles; however, this photo does not demonstrate repairs of all the areas observed by our investigators to be in poor condition. If you have not implemented all corrections, please provide a timeline as to when uncompleted corrections will be fully implemented. If you have implemented other corrections, please provide documentation of those corrections. You also stated that you advised employees of proper handling procedures for the pins and racks but did not provide documentation of these procedures or the specific handling procedures on which the employees were advised. We will evaluate the adequacy of your corrective actions during our next inspection.

4. Your equipment and utensils were not designed and constructed to be adequately cleanable and maintained to protect against allergen cross-contact and contamination, as required by 21 CFR 117.40. Specifically,

a. (b)(4) baking pans for loaves of (b)(4) bread were severely broken with jagged edges and crevices that make it difficult to clean or maintain them in a sanitary manner. The bread is baked directly on the pans with no liner. Similar observations were made during our previous inspections.

b. Cutting boards used for RTE bread were observed with deep grooves, badly scored surfaces, and dark stains. The score marks were deep enough to penetrate through the cutting board, exposing the fiber of the board. Similar observations were made during our previous inspections.

c. Mixer bowls used for preparing pastry dough have welds on the inside that were not smooth. During the (b)(4) process, residual dough may accumulate in the crevices, survive the cleaning process, and provide an environment for the potential growth of pathogens. A mixer bowl was observed to have a piece of (b)(4) scouring pad snagged on the welds after being cleaned and ready for use.

d. A brush used to glaze RTE pastries with a confectionary solution had a reservoir between the metal band and the wooden handle. This reservoir had accumulation of old food particles, even after cleaning, which can support the growth of pathogens. After our investigators pointed out the condition of this brush, you discarded it during our inspection.

e. During the dough forming process for the loaves of bread, it was observed that the dough routinely passes under a chain-link sheet that is not smooth and easily cleanable. The sheet had heavy accumulation of dried and moist raw dough.

In your response you indicated that you have replaced all the broken pans, cutting boards, and paint brushes. You stated that the welds on the mixing bowls have all been smoothed out. However, you did not provide any documentation that these corrections have been achieved. If you have implemented corrections, please provide documentation, such as invoices and photos. If you have not fully implemented corrections, please provide a timeline as to when these corrections will be implemented. We will verify the adequacy of your corrective actions during our next inspection.

5. All persons working in direct contact with food, food-contact surfaces, and food packaging materials did not conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and contamination of food, as required by 21 CFR 117.10(b). Specifically,

a. An employee was observed grabbing (b)(4) dough from the (b)(4) mixer such that the dough came into contact with his bare forearms and soiled clothes. Another employee was observed leaning on cutting boards with their bare forearms and elbows in direct contact with the food contact surface of the cutting board. Similar observations were made during our previous inspections.

b. Several employees were observed moving racks, adjusting equipment, moving trash bins, scratching their faces, adjusting their hairnets and then using their bare hands to shape raw bread dough without washing their hands. Similar observations were made during our previous inspections.

c. Several of the hand wash sinks located throughout the facility were missing either soap or paper towels. Similar observations were made during our previous inspections.

Your response stated that you have trained all your employees on handwashing and proper handling of dough. However, you did not provide any documentation that these corrections had been achieved or provide details of training content. If you have fully implemented these corrections, you may provide documentation of such with your response to this letter. If you have not fully implemented these corrections, please provide a timeline as to when these corrections will be fully implemented. If you have implemented other corrections not listed, please provide documentation of those corrections. We will evaluate and verify the adequacy of your corrective actions during our next inspection.

6. Your floors are not constructed in such a manner that they may be adequately cleaned and kept in good repair, as required by 21 CFR 117.20(b)(4). Specifically, during the inspection our investigators observed several puddles of soiled water in multiple holes, dents, and cracks along the floor. During processing, RTE bread on racks is rolled through these puddles, potentially splashing soiled water onto the exposed bread being held on the racks. Additionally, the floor drain located in the hallway between the (b)(4) mixers and proofing rooms was clogged and pooling soiled water. Similar observations were made during our previous inspections.

Your response stated that you have repaired all holes in the floor and fixed all drains. However, you did not provide any documentation that these corrections have been made. If these corrections have been fully achieved, please supply documentation of that. If you have not fully implemented these corrections, please provide a timeline as to when these corrections will be fully implemented. If you have implemented other corrections not listed, please provide documentation of those corrections. We will verify the adequacy of your corrective actions during our next inspection.

Failure to Register Food Facility:

Your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d], and our implementing regulation at 21 CFR Part 1, Subpart H. During the inspection of your facility located at 2460 West 1st Avenue, Hialeah, Florida, you were advised of this requirement.  (b)(3). Failure to register a facility as required is a prohibited act under section 301(dd) of the Act [U.S.C. § 331(dd)].

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are following the law.

We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of date of this letter. Registration may be completed online at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.

Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility’s owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA’s food registration form, Form FDA 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 1-301-575-0156 or by writing to the agency at the following address:

U.S. Food and Drug Administration
Food Facility Registration
5001 Campus Drive
HFS-681
College Park, MD 20993

When completed, the form may be faxed to (301) 436-2804 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility’s registration number using the same method used to submit the registration to FDA.

The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment and the products that you manufacture are in compliance with all requirements of the Act and applicable federal regulations. You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.

Section 743 of the Act, (21 USC 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 non-compliance materially related to a food safety requirement of the 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 re-inspection and assessing and collecting the re-inspection fees, [21 USC 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

You are encouraged to respond in writing within fifteen (15) working days of the receipt of this letter with the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. You should include documentation in your response, including photographs, food safety plans(s), procedures, or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Please send your reply to the Food and Drug Administration, San Juan District Office, 466 Fernández Juncos Avenue, San Juan, PR 00901-3223, to the attention of Mr. Ramon A. Hernandez, Director.

If you have any questions regarding this letter, please contact Ms. Laura Kennedy, Compliance Officer, at (813) 915-7948 or via e-mail at Laura.Kennedy@fda.hhs.gov.

Sincerely,
/S/

Ramon A. Hernandez
District Director, San Juan District
Program Division Director,
Office of Human and Animal Food Operations,
East Division IV

 
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