Listeria in facility and in product
- FDA "found that nineteen (19) swabs were confirmed positive for L. monocytogenes. Of the positive findings, one (1) swab was collected from the food-contact surface of a prep table in the (b)(4) Room used in the assembling of your RTE closed faced sandwiches, and one (1) swab was collected from the food-contact surface of a black milk crate holding raw tomatoes and onion used in RTE closed faced sandwiches and salads. This was not the first time L. monocytogenes was found in environmental samples collected in your facilities building. In 2020, FDA detected L. monocytogenes in six (6) environmental swabs; in 2018, FDA detected L. monocytogenes in nine (9) environmental swabs; and in 2017 FDA detected L. monocytogenes in eighteen (18) environmental swabs."
- "Based on the results of the WGS analysis, these isolates represent eighteen (18) different strains of L. monocytogenes. The WGS analysis identified multiple strains of L. monocytogenes isolated over multiple years which is indicative of the presence of resident pathogens or harborage sites in your facility."
- Many of these strains were found in different product samples tested since 2015.
GMP issues
- Ineffective measures to exclude pests from packing and holding areas with sightings of cockroaches and flies.
- Drip / condensate falling from from fixtures, ducts and pipes
- Improper cleaning including the use of unclean utensils
- Inadequate temperatures control
As of this issuance, the company looks to be be permanently closed.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wise-spice-catering-company-640715-03082023
FDA Warning Letter - Wise Spice Catering Company
Recipient:
Mr. Alexander Casanova, Mr. Gilberto Broche, Ms. Adiayn Gil
Owners
Wise Spice Catering Company
196 West 25th Street
Hialeah, FL 33010-1608
United States
alexcasanova70@hotmail.com
brochego@icloud.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
WARNING LETTER
3/8/23
23- HAFE4-WL-03 / CMS No. 640715
Dear Messrs. Casanova and Broche and Ms. Gil:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) food facility, which manufactures a number of RTE products including sandwiches and meals, located at 196 W 25th St, Hialeah, Florida, from April 19, 2022 through August 01, 2022. During our inspection of your facility, FDA investigators 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). During this inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility.
Based on FDA’s inspectional findings and the analytical results for samples collected from your production environment, we have determined that the RTE 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 contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and 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, the FDA investigators issued your facility a Form 483 (FDA-483), Inspectional Observations. We received your responses to the sample findings and Form 483 (FDA-483) on May 18, 2022, May 19, 2022, May 24, 2022, May 26, 2022, June 28, 2022, and October 4, 2022, describing corrective actions taken by your firm. Based on our review of the inspectional findings and the responses that your firm 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.
Pathogen Findings
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to apply controls or take corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
FDA’s current inspection included the collection of environmental swabs which found that nineteen (19) swabs were confirmed positive for L. monocytogenes. Of the positive findings, one (1) swab was collected from the food-contact surface of a prep table in the (b)(4) Room used in the assembling of your RTE closed faced sandwiches, and one (1) swab was collected from the food-contact surface of a black milk crate holding raw tomatoes and onion used in RTE closed faced sandwiches and salads. This was not the first time L. monocytogenes was found in environmental samples collected in your facilities building. In 2020, FDA detected L. monocytogenes in six (6) environmental swabs; in 2018, FDA detected L. monocytogenes in nine (9) environmental swabs; and in 2017 FDA detected L. monocytogenes in eighteen (18) environmental swabs.
On May 6, 2022, the United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) notified FDA of one (1) environmental sample collected from non-food contact surfaces at your facility which tested positive for L. monocytogenes. This was not the first time L. monocytogenes was found by USDA/FSIS in environmental samples collected in your facilities building. In 2015, USDA/FSIS also detected L. monocytogenes in one (1) environmental sample.
Moreover, on May 31, 2022, Florida Department of Agriculture and Consumer Services (FDACS) collected finished product samples of a Ham, Egg and Cheese Sandwich and a Beef, Beans Rice Cheese Burrito (contained (b)(4)% beef) which both tested positive for L. monocytogenes. On June 10, 2022, FDACS issued you a Stop Sales Order and Destruction for your sandwich products and issued a Stop Use Order on your (b)(4) Preparation Room, preventing the use of this room in your manufacturing operation. This is not the first time FDACS has isolated L. monocytogenes from your finished products; in 2015 finished product samples of a Tuna Sandwich, Ham Sandwich, Midnight Regular Sandwich, Ham Wrap Sandwich, Deli Ham Sandwich, and Ham Omelet Sandwich tested positive for L. monocytogenes.
Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples, USDA/FSIS environmental samples, and FDACS product samples. Based on the results of the WGS analysis, these isolates represent eighteen (18) different strains of L. monocytogenes. The WGS analysis identified multiple strains of L. monocytogenes isolated over multiple years which is indicative of the presence of resident pathogens or harborage sites in your facility. We advised you of the WGS results and its importance on June 21, 2022. Of the eighteen (18) identified strains, the following nine (9) strains of are particular significance:
One (1) strain includes isolates from FDA environmental samples collected from your facility in 2022, 2020, 2018, and 2017, the May 31, 2022 FDACS product sample of Ham Egg Cheese Sandwich which was manufactured at your facility, an environment sample collected from non-food contact surfaces at your facility in 2022 by USDA/FSIS, and environmental samples collected from other firm(s) located in Florida.
One (1) strain includes an isolate from your Beef Beans Rice Cheese Burrito product sample collected by FDACS on May 31, 2022, which does not match any other food, environmental, or clinical isolates in the National Center for Biotechnology Information (NCBI) Pathogen Detection database.
One (1) strain includes isolates from FDA environmental samples collected from your facility in 2017 and a 2015 FDACS product sample of Tuna Sandwich which was manufactured at your facility.
One (1) strain includes isolates from an FDA environmental sample collected from your facility in 2017, a 2015 FDACS product sample of Ham Sandwich which was manufactured at your facility, an environment sample collected from non-food contact surfaces at your facility in 2015 by USDA/FSIS, an environmental sample collected from another of your sandwich manufacturing facilities (Charanga Catering, LLC located in Florida), and an environmental sample collected from one (1) firm located in Florida.
One (1) strain includes isolates from FDA environmental samples collected from your facility in 2022, a 2015 FDACS product sample of Ham Omelet Sandwich which was manufactured at your facility, and environmental and product isolates collected from other firm(s) located in Florida.
One (1) strain includes isolates from FDA environmental samples collected from your facility in 2018 and 2017, a 2015 FDACS product sample of a Midnight Regular Sandwich which was manufactured at your facility, and environmental and product samples collected from other firm(s) located in Florida.
One (1) strain includes isolates from FDA environmental samples collected from your facility in 2017, 2015 FDACS product samples of a Deli Ham Sandwich and Ham Wrap Sandwich, which were manufactured at your facility, and environmental and product isolates collected from other firm(s) located in Florida.
One (1) strain includes isolates from FDA environmental samples collected from your facility in 2022 and 2020, four (4) samples collected from ill people which were deposited in the public repository at the NCBI between 2014 and 2021, and UDSA/FSIS food and environmental isolates collected from firms located in Florida, Texas and New York. These findings demonstrate that this strain is known to cause human illness.
One (1) strain includes isolates from an FDA environmental sample collected from your facility in 2022, a sample collected from an ill person which was deposited in the public repository at the NBCI in 2016 and food samples collected by USDA Agricultural Research Service. These findings demonstrate that this strain is known to cause human illness.
The presence of L. monocytogenes in your facility and your products is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food. Appropriate control of L. monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the corresponding hygienic practices necessary to control this pathogen. Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism.
In response to the current L. monocytogenes findings, you performed cleaning and sanitizing activities in your production area including utensils, equipment, processing tables and floors; disposed of a contaminated processing table, and hired a sanitation supervisor and a consultant. Further, you stated that your (b)(4). While you did note that you “(b)(4),” you provided limited information regarding the sampling frequency, target organism analyzed, and details contextualizing your sample collection. Further, your response did not include any information regarding conducting a root cause analysis to identify any potential niche or harborage areas to address any potential routes of contamination; you did not provide an updated copy of your Listeria Control Plan, and although you note that a training session was offer to your HACCP team, it is unclear if any refresher training was conducted for all of your employees.
Given the history and current inspection findings, we continue to be concerned about your ability to maintain a sanitary environment. We recommend that you identify potential harborage sites and source(s) of the organism in your processing environment and implement the necessary methods and controls to ensure L. monocytogenes does not contaminate your environment or your RTE food products. Additionally, it would be beneficial if your firm has awareness for the sources of your incoming ingredients to ensure that potential routes of contamination could be mitigated. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. You did not take effective measures to exclude pests from your 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, insect activity was observed throughout your facility including the following:
a. One (1) live apparent cockroach was observed on an empty brown plastic crate used to store and transport RTE packaged foods for customer orders, with crate directly next to stainless steel packaging tables in the front packaging/sales area.
b. Approximately eight (8) live apparent cockroaches were observed moving between metal panel and wall, and on the floor next to large kettles used for meat and black beans next to the side exit door in the shared USDA-regulated kitchen area.
c. One (1) apparent live German cockroach was observed crawling on the floor outside the FDA-regulated kitchen moving towards the wash room.
d. Apparent flies, too numerous to count, were observed throughout various processing areas of the facility including: the front packaging and sales area with flies landing on scales, equipment and packages of cooked ready-to-eat foods such as rice, beans, eggs, and fries; inside the kitchen during food preparation and packaging; and dry storage area.
e. Two (2) apparent flies were observed landing on an uncovered metal tray of cooked yuca in the front sales and packaging area, prior to an employee moving the tray inside the walk-in cooler to be cooled.
f. A plastic tray with packages of rice, beans, and plantains was observed with apparent bird excreta in the front sales area.
2. Your plant is not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminating food, food contact surfaces, or food packaging materials, as required by 21 CFR 117.20(b)(4). Specifically,
a. Condensation was observed on the underside of condensing unit located directly above stainless-steel processing table used to manufacture closed-face sandwiches; and was observed dripping onto surface of processing table, inside the (b)(4) processing room.
b. Condensation was observed on the black pipe cover under condensing unit, directly above a storage rack used to store raw materials, dripping onto a cardboard box with margarine and onto the floor inside (b)(4) #1.
3. You did not maintain your plant in a clean and sanitary conditions, and you did not clean and sanitize your utensils or equipment in a manner that protects against contamination, as required by 21 CFR 117.35(a). Specifically,
a. During our inspection our investigators observed stagnant water on a number of occasions, including on the floor and around floor drains in the front sales and food preparation area, on the floor with cracks and patches under storage racks holding cooked rice; on missing patches of floor near condensing unit inside (b)(4) #1 used to store RTE food products such as closed-faced sandwiches; and on missing patches of floor at entrance to the (b)(4) room.
b. An employee preparing to make RTE closed face sandwiches used an unclean knife to cut open packages of cooked deli ham blocks. The employee brought the knife from the USDA-regulated processing side and did not clean or sanitize the knife prior to cutting. Additionally, the investigator observed the knife had orange dried food residue near the white handle.
4. You did not hold food that can support the rapid growth of undesirable microorganism at temperatures that will prevent the food from being adulterated, as required by 21 CFR 117.80(c)(3). Specifically, your firm did not hold your RTE food products at adequate temperatures. Our investigators observed RTE food products being held in your customer sales area under ambient conditions for an extended period of time.
Specifically,
a. Our investigators observed that on April 21, 2022, from (b)(4) to (b)(4), your scrambled eggs with onion and peppers product was available for sale. Our investigators measured your product temperature using an FDA calibrated thermometer, reporting that your scrambled eggs with onion and peppers product temperature was (b)(4)°F (b)(4) hours after its preparation.
b. Our investigators observed that on April 21, 2022, from (b)(4) to (b)(4) your boiled cassava “yuca” product was available for sale. Our investigators measured your product temperature using an FDA calibrated thermometer, reporting that your boiled cassava “yuca” product temperature was (b)(4)°F (b)(4) hours after its preparation.
Your response focused on addressing the L. monocytogenes findings and did not address the remainder of the observations listed on the FDA-483. You indicated that you repaired your floors, repaired your draining system, replaced defective drains, and replaced damaged cooler doors, but you did not identify corrective actions taken to address each of our noted observations (e.g., condensate and food holding temperatures). You informed our investigators of your long-term plan to repair and improve your facility conditions. We will evaluate the adequacy of your corrective actions during our next inspection.
The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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. You should take prompt action to correct or implement corrections to the violations cited in this letter. 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.
Please notify this office in writing within 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 documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.
Your written response should be directed to the Food and Drug Administration, attention to: Mr. Ramon Hernández, Program Division Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact, Ms. Marilyn Santiago, Compliance Officer, at (787) 729-8707 or via email at Marilyn.santiago@fda.hhs.gov.
Sincerely,
/S/
Ramon A. Hernandez
Program Division Director
Office of Human and Animal Food Operations-
East Division 4
Mr. Alexander Casanova, Mr. Gilberto Broche, Ms. Adiayn Gil
Owners
Wise Spice Catering Company
196 West 25th Street
Hialeah, FL 33010-1608
United States
alexcasanova70@hotmail.com
brochego@icloud.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
WARNING LETTER
3/8/23
23- HAFE4-WL-03 / CMS No. 640715
Dear Messrs. Casanova and Broche and Ms. Gil:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) food facility, which manufactures a number of RTE products including sandwiches and meals, located at 196 W 25th St, Hialeah, Florida, from April 19, 2022 through August 01, 2022. During our inspection of your facility, FDA investigators 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). During this inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility.
Based on FDA’s inspectional findings and the analytical results for samples collected from your production environment, we have determined that the RTE 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 contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and 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, the FDA investigators issued your facility a Form 483 (FDA-483), Inspectional Observations. We received your responses to the sample findings and Form 483 (FDA-483) on May 18, 2022, May 19, 2022, May 24, 2022, May 26, 2022, June 28, 2022, and October 4, 2022, describing corrective actions taken by your firm. Based on our review of the inspectional findings and the responses that your firm 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.
Pathogen Findings
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to apply controls or take corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
FDA’s current inspection included the collection of environmental swabs which found that nineteen (19) swabs were confirmed positive for L. monocytogenes. Of the positive findings, one (1) swab was collected from the food-contact surface of a prep table in the (b)(4) Room used in the assembling of your RTE closed faced sandwiches, and one (1) swab was collected from the food-contact surface of a black milk crate holding raw tomatoes and onion used in RTE closed faced sandwiches and salads. This was not the first time L. monocytogenes was found in environmental samples collected in your facilities building. In 2020, FDA detected L. monocytogenes in six (6) environmental swabs; in 2018, FDA detected L. monocytogenes in nine (9) environmental swabs; and in 2017 FDA detected L. monocytogenes in eighteen (18) environmental swabs.
On May 6, 2022, the United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) notified FDA of one (1) environmental sample collected from non-food contact surfaces at your facility which tested positive for L. monocytogenes. This was not the first time L. monocytogenes was found by USDA/FSIS in environmental samples collected in your facilities building. In 2015, USDA/FSIS also detected L. monocytogenes in one (1) environmental sample.
Moreover, on May 31, 2022, Florida Department of Agriculture and Consumer Services (FDACS) collected finished product samples of a Ham, Egg and Cheese Sandwich and a Beef, Beans Rice Cheese Burrito (contained (b)(4)% beef) which both tested positive for L. monocytogenes. On June 10, 2022, FDACS issued you a Stop Sales Order and Destruction for your sandwich products and issued a Stop Use Order on your (b)(4) Preparation Room, preventing the use of this room in your manufacturing operation. This is not the first time FDACS has isolated L. monocytogenes from your finished products; in 2015 finished product samples of a Tuna Sandwich, Ham Sandwich, Midnight Regular Sandwich, Ham Wrap Sandwich, Deli Ham Sandwich, and Ham Omelet Sandwich tested positive for L. monocytogenes.
Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples, USDA/FSIS environmental samples, and FDACS product samples. Based on the results of the WGS analysis, these isolates represent eighteen (18) different strains of L. monocytogenes. The WGS analysis identified multiple strains of L. monocytogenes isolated over multiple years which is indicative of the presence of resident pathogens or harborage sites in your facility. We advised you of the WGS results and its importance on June 21, 2022. Of the eighteen (18) identified strains, the following nine (9) strains of are particular significance:
One (1) strain includes isolates from FDA environmental samples collected from your facility in 2022, 2020, 2018, and 2017, the May 31, 2022 FDACS product sample of Ham Egg Cheese Sandwich which was manufactured at your facility, an environment sample collected from non-food contact surfaces at your facility in 2022 by USDA/FSIS, and environmental samples collected from other firm(s) located in Florida.
One (1) strain includes an isolate from your Beef Beans Rice Cheese Burrito product sample collected by FDACS on May 31, 2022, which does not match any other food, environmental, or clinical isolates in the National Center for Biotechnology Information (NCBI) Pathogen Detection database.
One (1) strain includes isolates from FDA environmental samples collected from your facility in 2017 and a 2015 FDACS product sample of Tuna Sandwich which was manufactured at your facility.
One (1) strain includes isolates from an FDA environmental sample collected from your facility in 2017, a 2015 FDACS product sample of Ham Sandwich which was manufactured at your facility, an environment sample collected from non-food contact surfaces at your facility in 2015 by USDA/FSIS, an environmental sample collected from another of your sandwich manufacturing facilities (Charanga Catering, LLC located in Florida), and an environmental sample collected from one (1) firm located in Florida.
One (1) strain includes isolates from FDA environmental samples collected from your facility in 2022, a 2015 FDACS product sample of Ham Omelet Sandwich which was manufactured at your facility, and environmental and product isolates collected from other firm(s) located in Florida.
One (1) strain includes isolates from FDA environmental samples collected from your facility in 2018 and 2017, a 2015 FDACS product sample of a Midnight Regular Sandwich which was manufactured at your facility, and environmental and product samples collected from other firm(s) located in Florida.
One (1) strain includes isolates from FDA environmental samples collected from your facility in 2017, 2015 FDACS product samples of a Deli Ham Sandwich and Ham Wrap Sandwich, which were manufactured at your facility, and environmental and product isolates collected from other firm(s) located in Florida.
One (1) strain includes isolates from FDA environmental samples collected from your facility in 2022 and 2020, four (4) samples collected from ill people which were deposited in the public repository at the NCBI between 2014 and 2021, and UDSA/FSIS food and environmental isolates collected from firms located in Florida, Texas and New York. These findings demonstrate that this strain is known to cause human illness.
One (1) strain includes isolates from an FDA environmental sample collected from your facility in 2022, a sample collected from an ill person which was deposited in the public repository at the NBCI in 2016 and food samples collected by USDA Agricultural Research Service. These findings demonstrate that this strain is known to cause human illness.
The presence of L. monocytogenes in your facility and your products is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food. Appropriate control of L. monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the corresponding hygienic practices necessary to control this pathogen. Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism.
In response to the current L. monocytogenes findings, you performed cleaning and sanitizing activities in your production area including utensils, equipment, processing tables and floors; disposed of a contaminated processing table, and hired a sanitation supervisor and a consultant. Further, you stated that your (b)(4). While you did note that you “(b)(4),” you provided limited information regarding the sampling frequency, target organism analyzed, and details contextualizing your sample collection. Further, your response did not include any information regarding conducting a root cause analysis to identify any potential niche or harborage areas to address any potential routes of contamination; you did not provide an updated copy of your Listeria Control Plan, and although you note that a training session was offer to your HACCP team, it is unclear if any refresher training was conducted for all of your employees.
Given the history and current inspection findings, we continue to be concerned about your ability to maintain a sanitary environment. We recommend that you identify potential harborage sites and source(s) of the organism in your processing environment and implement the necessary methods and controls to ensure L. monocytogenes does not contaminate your environment or your RTE food products. Additionally, it would be beneficial if your firm has awareness for the sources of your incoming ingredients to ensure that potential routes of contamination could be mitigated. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. You did not take effective measures to exclude pests from your 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, insect activity was observed throughout your facility including the following:
a. One (1) live apparent cockroach was observed on an empty brown plastic crate used to store and transport RTE packaged foods for customer orders, with crate directly next to stainless steel packaging tables in the front packaging/sales area.
b. Approximately eight (8) live apparent cockroaches were observed moving between metal panel and wall, and on the floor next to large kettles used for meat and black beans next to the side exit door in the shared USDA-regulated kitchen area.
c. One (1) apparent live German cockroach was observed crawling on the floor outside the FDA-regulated kitchen moving towards the wash room.
d. Apparent flies, too numerous to count, were observed throughout various processing areas of the facility including: the front packaging and sales area with flies landing on scales, equipment and packages of cooked ready-to-eat foods such as rice, beans, eggs, and fries; inside the kitchen during food preparation and packaging; and dry storage area.
e. Two (2) apparent flies were observed landing on an uncovered metal tray of cooked yuca in the front sales and packaging area, prior to an employee moving the tray inside the walk-in cooler to be cooled.
f. A plastic tray with packages of rice, beans, and plantains was observed with apparent bird excreta in the front sales area.
2. Your plant is not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminating food, food contact surfaces, or food packaging materials, as required by 21 CFR 117.20(b)(4). Specifically,
a. Condensation was observed on the underside of condensing unit located directly above stainless-steel processing table used to manufacture closed-face sandwiches; and was observed dripping onto surface of processing table, inside the (b)(4) processing room.
b. Condensation was observed on the black pipe cover under condensing unit, directly above a storage rack used to store raw materials, dripping onto a cardboard box with margarine and onto the floor inside (b)(4) #1.
3. You did not maintain your plant in a clean and sanitary conditions, and you did not clean and sanitize your utensils or equipment in a manner that protects against contamination, as required by 21 CFR 117.35(a). Specifically,
a. During our inspection our investigators observed stagnant water on a number of occasions, including on the floor and around floor drains in the front sales and food preparation area, on the floor with cracks and patches under storage racks holding cooked rice; on missing patches of floor near condensing unit inside (b)(4) #1 used to store RTE food products such as closed-faced sandwiches; and on missing patches of floor at entrance to the (b)(4) room.
b. An employee preparing to make RTE closed face sandwiches used an unclean knife to cut open packages of cooked deli ham blocks. The employee brought the knife from the USDA-regulated processing side and did not clean or sanitize the knife prior to cutting. Additionally, the investigator observed the knife had orange dried food residue near the white handle.
4. You did not hold food that can support the rapid growth of undesirable microorganism at temperatures that will prevent the food from being adulterated, as required by 21 CFR 117.80(c)(3). Specifically, your firm did not hold your RTE food products at adequate temperatures. Our investigators observed RTE food products being held in your customer sales area under ambient conditions for an extended period of time.
Specifically,
a. Our investigators observed that on April 21, 2022, from (b)(4) to (b)(4), your scrambled eggs with onion and peppers product was available for sale. Our investigators measured your product temperature using an FDA calibrated thermometer, reporting that your scrambled eggs with onion and peppers product temperature was (b)(4)°F (b)(4) hours after its preparation.
b. Our investigators observed that on April 21, 2022, from (b)(4) to (b)(4) your boiled cassava “yuca” product was available for sale. Our investigators measured your product temperature using an FDA calibrated thermometer, reporting that your boiled cassava “yuca” product temperature was (b)(4)°F (b)(4) hours after its preparation.
Your response focused on addressing the L. monocytogenes findings and did not address the remainder of the observations listed on the FDA-483. You indicated that you repaired your floors, repaired your draining system, replaced defective drains, and replaced damaged cooler doors, but you did not identify corrective actions taken to address each of our noted observations (e.g., condensate and food holding temperatures). You informed our investigators of your long-term plan to repair and improve your facility conditions. We will evaluate the adequacy of your corrective actions during our next inspection.
The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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. You should take prompt action to correct or implement corrections to the violations cited in this letter. 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.
Please notify this office in writing within 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 documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.
Your written response should be directed to the Food and Drug Administration, attention to: Mr. Ramon Hernández, Program Division Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact, Ms. Marilyn Santiago, Compliance Officer, at (787) 729-8707 or via email at Marilyn.santiago@fda.hhs.gov.
Sincerely,
/S/
Ramon A. Hernandez
Program Division Director
Office of Human and Animal Food Operations-
East Division 4
No comments:
Post a Comment