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WARNING LETTER

Tugusto Foods, Inc. MARCS-CMS 587608 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Jaime Franco Salamanca
Recipient Title
President
Tugusto Foods, Inc.

Urb. Industrial Minillas
E Street, Building M-H 0959, Lot 1
Bayamón 00919
Puerto Rico

Issuing Office:
Office of Human and Animal Foods Division 4 East

United States



WARNING LETTER

20-HAFE4-WL-04/CMS No. 587608


Dear Mr. Salamanca:

The United States Food and Drug Administration (FDA) inspected your manufacturing facility, located at Urb. Industrial Minillas, E Street Building M-H 0959, Lot 1, Bayamón, PR 00919, on May 07-08, 2019, and June 7, 2019, where you manufacture and repack Ready-to-Eat (RTE) seasonings and spices products. 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 determined that the food products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive 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)).

Further, during our inspection of your facility, we collected labeling for several of your Ready-to-Eat (RTE) seasoning products, including Tugusto Chef Sazón con Culantro y Achiote, Sazón Tugusto Agrandador de Sabor, and Tugusto Bijaol Condimento Para Sabor y Color. FDA reviewed these product labels and found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343). You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at http://www.fda.gov.

At the conclusion of the inspection, FDA issued a form FDA-483, Inspectional Observations, listing the deviations found at your firm. Subsequently, we received your written response dated June 26, 2019, describing corrective actions taken by your firm. Your response is addressed below.

Your significant CGMP & PC violations are as follows:

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

The CGMP & PC rule creates new requirements for covered facilities to perform a hazard analysis and establish and implement risk-based preventive controls for human food. The CGMP & PC rule provides that you must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control [21 CFR § 117.130(a)]. The CGMP & PC rule further provides that you must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under Section 402 of the Act or misbranded under Section 403(w) of the Act [21 CFR § 117.135(a)(1)].

Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135). Preventive controls are subject to preventive control management components 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).

1. You did not prepare, or have prepared, and did not implement a food safety plan for the food products manufactured in your facility (including seasonings and spices), as required by 21 CFR § 117.126(a)(1). 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).

2. You did not conduct a hazard analysis for any of your products to 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 pathogens as a known or reasonably foreseeable hazard to determine whether pathogens are a hazard requiring a preventive control. Your facility manufactures various seasoning and spice products (b)(4) Pathogen contamination has been associated with ingredients in seasonings and spice products that have not undergone lethal treatment and are used in manufacturing.

b. You did not identify mycotoxins as a known or reasonably foreseeable hazard to determine whether mycotoxins are a hazard requiring a preventive control. Your facility manufactures various products (b)(4) These ingredients have been associated with mycotoxins.

c. You did not evaluate environmental pathogens, such as Salmonella, as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control, to comply with 21 CFR § 117.130(c)(1)(ii). Specifically, your facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen or control by the supply chain or downstream customer) that would significantly minimize the pathogen.

Your response indicates that you hired a consulting firm, (b)(4) to develop your Food Safety Plan (FSP) by the end of August 2019. However, it is not clear if (b)(4) will be developing an FSP for your firm because it is not outlined in the Service Agreement that was sent to FDA. It appears that (b)(4) will only be conducting a mock food safety audit at your firm concerning your firm's compliance with 21 CFR Part 117, subpart B (CGMPs), and will provide your firm with a written or oral report describing observations. The audit will not document your firm's compliance with the Preventive Controls requirements. Furthermore, the agreement does not specify if a written hazard analysis will be conducted for your firm, including developing written preventive control programs and procedures. The adequacy of your food safety plan, including your hazard analysis and related procedures, will be verified during the next inspection.

Current Good Manufacturing Practice (Subpart B)

3. You did not take effective measures to exclude pests from your food plant and to protect against contamination of food, as required by 21 CFR Part 117.35(c). Specifically, on May 7, 2019, and May 8, 2019, your firm manufactured “Sazón con Culantro y Achiote” (Seasoning with (b)(4)) (b)(4)oz. and (b)(4)lbs. and also repacked “Agrandador de Sabor” ((b)(4)) (b)(4)oz.

On those days,

a. At the entrance of the production and packing area, inside your facility, your firm had an (b)(4) bait station with bait. Next to this rodent bait station our investigator observed what appeared to be four (4) rodent excreta pellets.

b. Our investigator observed two (2) dead cockroaches, dirt, and pieces of dead insects on the floor of the warehouse next to pallets of finished products for distribution such as “Sazón con Culantro y Achiote” (Seasoning (b)(4)) (b)(4)oz., “Agrandador de Sabor” ((b)(4)) (b)(4)oz., food ingredients, and packaging materials. Additionally, a dead cockroach was observed on the floor of the production area next to a sink used for cleaning equipment and a mop and bucket used to clean the facility.

c. Our investigator observed a live fly inside of a (b)(4)lb. (b)(4) jar that an employee stated is used during repacking and comes into contact with spices. In the same area, an employee was repacking by hand “Agrandador de Sabor” ((b)(4)) (b)(4)oz. for which there were open jars and exposed finished product.

d. In close proximity to the production and packing areas, our investigator observed an accumulation of waste, wooden pallets, old paperwork, materials, and equipment in disuse which could serve as harborage and breeding areas for pests. Additionally, accumulated dust and fine product particles which could attract rodents and insects were observed on surfaces throughout the facility.

e. There was poor or no illumination in the warehouse where pallets of finished products and packaging materials were stored. In addition, pallets were stored against the walls. These conditions prevent your firm from properly inspecting for rodent and pest activity.

The following areas lacked protection against the entry of pests:

f. A screen gate leading from the outside of the plant to the interior of the warehouse and processing areas had gaps along the bottom and sides that ranged from (b)(4) to (b)(4) inches wide, providing ingress of insects and other pests into the processing area and other areas of the plant. Outside this gate was a dumpster, which can attract rodents and insects.

g. There was an opening approximately (b)(4) inches wide on a wall of the production area, which led to the exterior of the facility. A window screen covering this opening was detached from the wall, leaving your production facility exposed to the entry of pests.

Your response indicates that your firm hired a third party to provide pests control services. However, your response does not address the other deficiencies cited, including the gaps and openings observed throughout the facility, which allow the entry of pests and the poor illumination observed at the warehouse. Further, you do not indicate whether any measures will be implemented to prevent recurrence of the deviation, such as routine inspections of the facility to detect the presence of pest activity.

4. You did not conduct operations under conditions and controls necessary to minimize the potential for growth of microorganisms, allergen cross-contact, contamination of food, and deterioration of food, as required by 21 CFR Part 117.80(c)(2). In addition, you did not maintain equipment and utensils and food containers in an adequate condition through appropriate cleaning and sanitizing, as required by 21 CFR Part 117.80(c)(1).

Specifically,

a. During production, employees (b)(4) An employee identified (b)(4) on all exterior surfaces of the mixer and other manufacturing equipment. The brushes were also used in the interior (food contact) surfaces of the mixer without being cleaned and sanitized before use. Your employee stated (b)(4)

b. (b)(4) production employees used dirty fabric mittens during (b)(4) of “Sazón con Culantro y Achiote” (Seasoning with (b)(4)) and repacking of “Agrandador de Sabor” ((b)(4)). The mittens showed orange-colored stains that an employee identified (b)(4) Your employee informed (b)(4) Between uses, these mittens were exposed to the environment and in direct contact with dirty surfaces throughout the facility. Specifically, your employees used mittens for handling dirty surfaces, such as the corroded parts of the (b)(4) drum used to collect ingredients, the forklift, dusty bags of ingredients, the brushes used to clean up the mixer, and plastic containers. These mittens were also used in the interior (food contact) surfaces of the mixer and capper machine without being cleaned and sanitized before use.

c. During the packaging activities of “Sazón con Culantro y Achiote” (Seasoning with (b)(4)) an employee lubricated the machinery of a (b)(4) machine wearing the fabric mittens and using a non-food grade lubricant oil. The same employee grabbed paper towels impregnated in oil and then handled the lids that were used to cap finished products. The employee did not remove the mittens and perform hand washing before touching the food contact surfaces of the lids. The employee wore the fabric mittens while touching dirty wooden pallets and a knife that was used to cut open carton boxes. In addition, the oil can was stored in the capper machine, along with the exposed products being packed.

d. Employees used filthy and deteriorated (b)(4) containers (trash cans) lined with a dirty reused blue (b)(4) bag for holding the finished blend of “Sazón con Culantro y Achiote” (Seasoning with (b)(4)) until packaging took place. Our investigator observed your employees placing and dragging these containers throughout the dirty production area floor. An employee also stated (b)(4) Our investigator also observed that the (b)(4) bags were stored on dirty (b)(4) pallets against a dirty and corroded (b)(4) rack before being reused inside the containers with the seasoning.

e. An employee formulating “Sazón con Culantro y Achiote” (Seasoning with (b)(4)) did not handle ingredients properly so as to prevent contamination during the addition of ingredients to the mixer. He did not clean the dust on the exterior of the bags of monosodium glutamate and salt before opening them. He also placed and dragged the bags of ingredients throughout the dirty production area floor. The employee then placed the bags inside of a (b)(4) drum and tapped the bags with his hands to empty them. The (b)(4) drum used to collect the ingredients was corroded and dusty; the lining was made of non-food grade plastic tape that was flaking. This tape could come off when ingredients are discharged from the drum, contaminating the finished product with plastic fragments. Our investigator observed dark particles that appeared to be rust fall from the corroded drum’s surface onto the ingredients in the mixer when the employee lifted the drum with a forklift and discharged its contents.

f. Dirty and deteriorated (b)(4) containers showing scratches and discoloration were used to hold ingredients such as egg yellow shade colorant, coriander, garlic, black pepper, and cumin. Some of these containers were not labeled to identify their contents. Employees used shared dirty scoops to collect these ingredients. These practices could contribute to the contamination of treated spices with pathogenic microorganisms.

g. Employees used a deteriorated filthy razor to cut and open the packages of ingredients. The razor had a customized handle made with pieces of cardboard and tape. These practices expose your food to physical hazards (e.g. metal fragments and other potentially hazardous foreign matter) and microbial hazards.

h. A yellow apron used in the manufacturing operations was hanging against a dusty wall and a dirty working table with spider webs.

i. Throughout the processing area and warehouse, you had toxic compounds (e.g., paint, roof sealer, non-food grade lubricants and degreasers, gasoline, herbicides, pesticides, and rodenticides) gardening equipment and tools, garbage, empty dirty buckets, waste left by your employees (e.g., empty dirty coffee cups) and employees’ personal belongings (e.g., boots, bags, and lunchboxes). All these items were improperly stored next to or near where in-process and finished products were exposed.

5. You did not ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials maintain cleanliness by washing their hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR Part 117.10(b)(3). Specifically, (b)(4) employees were observed not washing their hands or changing their gloves after using their cell phones or returning to their working stations after changing tasks. An employee packaging “Sazón con Culantro y Achiote” (Seasoning with (b)(4)) went to the bathroom with his gloves on, returned to his work station, and continued working wearing the same gloves. The employee changed his gloves when our investigator called his attention to the deficiency, but our investigator did not observe him re-washing his hands before donning new gloves. Our investigator observed that these employees had a box of disposable gloves available to change their gloves during manufacturing activities without having to go to the handwashing sink to re-wash their hands.

6. You did not provide hand-washing facilities designed to ensure that an employee's hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature, as required by 21 CFR Part 117.37(e). Specifically, your firm’s hand-washing facilities lacked hot water, paper towels or another suitable drying device.

7. You did not provide shatter-resistant light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage, as required by 21 CFR Part 117.20(b)(5). Specifically, several light fixtures did not have covers and/or shatter proof bulbs so that their light bulbs remained exposed over the food and packaging materials stored below. These conditions expose your food products to potential glass contamination.

8. You did not ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices by wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR Part 117.10(b)(6). Specifically, (b)(4) of your employees were observed not wearing beard nets during production and packaging. of the employees were working on the formulation of “Sazón con Culantro y Achiote” (Seasoning with (b)(4)), and (b)(4) was packaging the finished ready-to-eat product. Also, an employee was observed not wearing his hair restraint correctly, which left part of his hair exposed

9. You did not ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials remove unsecured jewelry and other objects that might fall into food, equipment, or containers to protect against allergen cross-contact and against contamination of food, as required by 21 CFR Part 117.10(b)(4). Specifically, an employee was observed wearing three stud earrings on his left ear.

Your response indicates that preventive controls will be implemented according to the FSP developed by your consultant. You did not provide any documentation of measures that will be implemented to assure conformance with CGMPs and how your firm will prevent these violations from recurring while the FSP is developed. In addition, you did not provide documentation or a timeframe of when and how the corrections it will be implemented.

Misbranding Violations

1. Your Tugusto Bijaol Condimento Para Sabor y Color product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because it fails to bear a Nutrition Facts label, as required by 21 CFR Part 101.9.

2. Your Tugusto Chef Sazón con Culantro y Achiote and Tugusto Bijaol Condimento Para Sabor y Color products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but they do not bear labels that include a complete list of all the ingredients by common or usual name, as required by 21 CFR Part 101.4.

For example:

a. Your Tugusto Chef Sazón con Culantro y Achiote product is manufactured using (b)(4) however, it fails to list the sub-ingredients “(b)(4)” and (b)(4). If the silicon dioxide ingredient serves as a chemical preservative and the term “anticompactante” (anticaking) refers to the ingredient’s function, it must be labeled in accordance with 21 CFR Part 101.22(j). Additionally, your Tugusto Chef Sazón con Culantro y Achiote product is manufactured using (b)(4) however, it fails to list the sub-ingredient “(b)(4)”.

b. Your Tugusto Bijaol Condimento Para Sabor y Color product is manufactured using (b)(4) but fails to declare these ingredients. Furthermore, your Tugusto Bijaol Condimento Para Sabor y Color product fails to declare all sub-ingredients of the multicomponent ingredient (b)(4) including (b)(4) Additionally, your Tugusto Bijaol Condimento Para Sabor y Color product fails to declare the sub-ingredients of the multicomponent ingredient (b)(4). If the (b)(4) ingredient serves as a chemical preservative and the term “(b)(4)” ((b)(4)) refers to the ingredient’s function, it must be labeled in accordance with 21 CFR Part 101.22(j). You stated during the inspection that your Tugusto Bijaol Condimento Para Sabor y Color product (b)(4) Your Tugusto Bijaol Condimento Para Sabor y Color product fails to declare the sub-ingredients (b)(4) or (b)(4) as appropriate.

According to 21 CFR Part 101.4(b)(2), the requirement to list component ingredients of a multi component ingredient (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

3. Your Tugusto Chef Sazón con Culantro y Achiote and Sazón Tugusto Agrandador de Sabor products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] in that the product labels bear the nutrient content claims “40% Menos Sodio Que La Sal (40% Less Sodium Than Salt)” and “60% Less Sodium Than Salt,” respectively, but fail to declare clear and concise quantitative information comparing the amount of sodium per declared serving in the products to that of the reference food (salt) as required by 21 CFR Part 101.13(j)(2)(iv) and 21 CFR Part 101.61(b)(6)(ii)(B). This statement shall appear adjacent to the most prominent nutrient content claim on the information panel.

4. Your Tugusto Bijaol Condimento Para Sabor y Color product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. The product label declares “Harina de Maíz” (Cornmeal), “Pimentón” (Red Pepper), and “Glicol de Propileno” (Propylene Glicol) as ingredients although these ingredients are not part of the product’s formulation.

This letter is not intended as an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable requirements. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.

In addition, we also offer the following comment regarding your product labeling:

  • As you may already know, FDA finalized new requirements for nutrition labeling on May 27, 2016. The new Nutrition Facts label includes updates to the required nutrient declarations and formatting requirements. Manufacturers may begin revising labels now to meet the new requirements. FDA extended the compliance dates for the Nutrition Facts label final rule and the Serving Size final rule, from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply – until January 1, 2021. For more information on the new requirements, please see https://www.fda.gov/food/food-labeling-nutrition/changes-nutrition-facts-label.

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. Re-inspection-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.

Please respond in writing within fifteen (15) working days from your receipt of this letter as to 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. 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.

Your written response should be directed to the U.S. Food and Drug Administration, attention to: Mr. Ramon A. Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact Ms. Beira Montalvo, Compliance Officer, at (561) 416-1108 ext. 1108 or via email at Beira.Montalvo@fda.hhs.gov.

Sincerely yours,
/S/

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