Six companies put on notice after FDA uncovers violations

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As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Martinez Mexican Produce LLC

Hidalgo, TX

An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In a June 16 warning letter, the FDA described March 6, 2020, Foreign Supplier Verification Program (FSVP) inspection at Martinez Mexican Produce LLC.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

  • Mayonnaise manufactured by (redacted)
  • Shredded coconut manufactured by (redacted)

The full warning letter can be viewed here.

Fides Ny Inc.

Bayside, NY

An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 29 warning letter, the FDA described May 26 and 28, 2020, Foreign Supplier Verification Program (FSVP) inspections at Fides New York Inc.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

  •  Namja Ramen imported from their foreign supplier, (redacted)
  •   Aloe Drink imported from their foreign supplier, (redacted)
  •   Frozen Yogurt Drink Green Apple Flavor imported from their foreign supplier, (redacted)

The full warning letter can be viewed here.

Grupo Rm Usa, Inc.

Miami, FL

An import company in Florida is on notice from the FDA for not having FSVPs for a number of imported food products.

In an Aug. 6 warning letter, the FDA described an April 30 and May 6, 2020, Foreign Supplier Verification Program (FSVP) inspection at Grupo Rm Usa, .

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

  • Tropical Banana Soft Drink, imported from (redacted).
  • Toasted Crackers, imported from (redacted).
  • Milk Candy, imported from (redacted).

The full warning letter can be viewed here.

La Sonorense, Inc.

Phoenix, AZ

A company in Arizona is on notice from the FDA for CGMP & PC violations, including not identifying and evaluating bacterial pathogens such as pathogenic E. coli, Salmonella, and Listeria monocytogenes, in their ingredients as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control.

In an Aug. 6 warning letter the FDA described a March 16 and 21, 2020, inspection at La Sonorense Inc.’s ready-to-eat food manufacturing facility. Inspectors found that the company had serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

FDA’s inspection resulted in issuance of an FDA Form 483. The significant violations are as follows:

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

  • The firm did not conduct a hazard analysis for any of their products to identify and evaluate known or reasonably foreseeable hazards for each type of food products manufactured or processed at their facility to determine whether there are any hazards requiring a preventive control. Specifically,
  1. The firm did not identify and evaluate undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control. Their facility receives, stores, and manufactures products that contain an allergen (wheat). FDA investigators observed their RTE pressed wheat flour tortillas were packaged into clear unlabeled packages, twist tied closed, and packed into a cardboard box. The bulk packaged RTE pressed wheat flour tortillas were not labeled with an ingredient statement declaring wheat flour as an ingredient. As a result of FDA inspection, their firm conducted a voluntary recall of their bulk Pressed Wheat Flour Tortillas that contain wheat flour as an ingredient due to undeclared wheat allergen on the product label.
  2. The firm did not identify and evaluate bacterial pathogens such as pathogenic E. coli, Salmonella, and Listeria monocytogenes in their ingredients as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. For example, pathogenic E. coli and Salmonella are known or reasonably foreseeable hazards in flour.
  3. The firm did not identify and evaluate environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard after their (redacted) step to determine whether the hazard requires a preventive control. Their facility manufactures RTE food which is exposed to the environment after the (redacted) step but 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.
  4. They did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control. Their facility manufactures tortillas with wheat and corn flour. These ingredients have been associated with mycotoxins.
  • The firm did not identify and implement preventive controls for any of their products to provide assurance that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated. 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. 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.
  • The firm did not prepare or have prepared and did not implement a written food safety plan for any of the products manufactured in their facility. A food safety plan must include the following:
  1. The written hazard analysis.
  2. The written preventive controls.
  3. The written supply-chain program.
  4. The written recall plan.
  5. The written procedures for monitoring the implementation of the preventive controls.
  6. The written corrective action procedures.
  7. The written verification procedures.

During the inspection, the company’s assistant manager stated the firm would conduct a hazard analysis and create a food safety plan after construction of their new facility, but no timeline for the creation of the food safety plan or new plant construction was provided. Their written response did not provide any details to address the hazard analysis or food safety plan.

Current Good Manufacturing Practice (Subpart B):

  • The firm did not take effective measures to exclude pests from their manufacturing, processing and packing areas to protect against the contamination of food, as required by 21 CFR § 117.35(c). Specifically, the FDA investigator observed:
  1. The (redacted) dock doors located on the east side of the facility remained open during each production day of the inspection, with employees, raw ingredients, and finished products passing in and out. The dock door is equipped with an (redacted) which did not appear to be functioning properly during the inspection. There was also a 1 to 2-inch wide gap under and in-between the sliding dock doors. During the production of (redacted)-inch wheat flour tortillas, an employee was seen placing proofed dough onto a dough feeder located approximately four feet from the open dock doors.
  2. Apparent rodent excreta pellets were present on top of a large plastic bin containing a mixture of (redacted) and (redacted) which was used as an (redacted) for boiling and soaking corn kernels.
  3. Flying insects, too numerous to count, were in the production area and landing on the wheat flour dough feeder and ovens, including one insect directly on top of the prep table as employees were packaging flour tortillas.

Similar observations were made during the 2018 and 2019 inspections. In their written response, company officials stated they are in the process of replacing the back door to repair the gaps, and they will retrain employees to ensure that the (redacted) are on at all times. The FDA will evaluate the adequacy of their corrective actions during the next inspection.

  • The firm’s equipment and utensils were not adequately maintained to protect against contamination. Specifically, on March 17, 2020, FDA investigators observed the plastic and metal portions of the belt on the feeder of the (redacted) Tortilla oven and (redacted) Tortilla oven were scarred and stained with  dark residue. A similar observation was made during the 2018 inspection. Their written response did not address this violation.
  • The firm did not clean and sanitize its utensils or equipment in a manner that protects against contamination. Specifically, FDA investigators observed their sanitation process, which consisted of scraping to remove residual dough and wiping down the RTE tortilla processing areas using a cleaner/degreaser in (redacted) water and a rag (redacted), but no sanitizer. Residual dough, approximately ¼ inch thick on the mixer, proofing boxes, metal sheet pans, and dough feeders, was observed after cleaning was performed. The large metal vat used to soak, and boil corn kernels contained standing water and had yellow and brown stains with residues measuring approximately ½ inch thick on the food contact surfaces. An employee used a metal scoop to remove standing water from the metal vat, but the vat was never cleaned prior to being used in food production. Furthermore, the (redacted) conveyors used to transport the baked tortillas to packaging were not cleaned. Similar observations were made during the 2018 and 2019 inspections.

The full warning letter can be viewed here.

Grand Strand Sandwich Company Inc.,

Longs, SC

A company in South Carolina is on notice front from the FDA for CGMP and PC violations, including the presence of Listeria monocytogenes found on four swabs collected from locations adjacent to food contact surfaces.

In an Aug. 4 warning letter the FDA described a Feb. 24-27, 2020, inspection at Grand Strand Sandwich Company Inc. ready-to-eat sandwich manufacturing facility. Inspectors found that the company had serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

FDA’s inspection resulted in issuance of an FDA Form 483. The significant violations are as follows:

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

  1. The firm did not identify and implement preventive controls adequate 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 their facility will not be adulterated.
  • In their food safety plan, they identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of Listeria monocytogenes in their facility, they did not implement sanitation controls adequate to ensure that their facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen Listeria monocytogenes.

Environmental swabs collected during each of the past three FDA inspections revealed Listeria  monocytogenes in their facility as follows:

– 2020: four (4) swabs collected from locations adjacent to food contact surfaces.

– 2018: seventeen (17) swabs primarily collected from food contact surfaces and locations adjacent to food contact surfaces.

– 2017: five (5) swabs within their facility primarily collected from locations adjacent to food contact surfaces.

Whole genome sequencing (WGS) was conducted on the Listeria monocytogenes isolates obtained from the FDA environmental samples. The current WGS analysis determined that the isolates derived from the samples collected at their facility during FDA 2020, 2018, and 2017 inspections represent a single strain of Listeria monocytogenes. These isolates are also genetically identical to one (1) clinical isolate collected in 2015, which indicates this strain has the capability of causing human illness. The FDA advised them of those WGS results via a conference call on March 25, 2020. The presence of the same strain of Listeria monocytogenes over multiple years indicates that there has been a resident pathogen or harborage site in their facility since 2017.

These findings demonstrate that their sanitation procedures have been inadequate to significantly minimize or prevent Listeria monocytogenes in their facility. Once Listeria  monocytogenes 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 areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.

In addition, on January 6, 2020, they found Listeria spp. on a (redacted) in their processing environment. Their firm implemented corrective actions, which included cleaning and sanitizing, followed by conducting environmental swabbing on that location to determine these were effective. On February 24, 2020, FDA’s environmental swabbing isolated Listeria monocytogenes from a (redacted) in their (redacted), which appears to be the same location of their January 6, 2020, finding.

In their written responses, they indicate that they have assessed potential routes of contamination, closed production on March 13, 2020, to perform deep cleaning and sanitizing, performed environmental swabbing, and purchased a (redacted) to use on hard-to-clean, high-risk areas of production. They also state that they are evaluating the use of a third-party consulting company to assist in re-evaluating their environmental monitoring program; however, they have not provided details on the completion of their consultation process, actions items that resulted from their consultation, or a timeframe for implementation of any additional corrective actions. Additionally, they state that they created an SSOP for changing gloves, created an SSOP for operating their (redacted), and re-trained their employees on both procedures; however, they did not provide any records that document their employees received the specified training.

As reflected in the inspectional findings and repeated detection of the same strain of Listeria monocytogenes in their facility, their previous actions have not been adequate to address the hazard of Listeria monocytogenes. Specifically, after the FDA’s 2017 inspection, they indicated that they contracted with a third-party cleaning service to conduct deep cleaning and sanitizing in their facility, and they were in consultation with (redacted), who performed a one day inspection at their facility and identified areas for improvement within their processing environment. After the FDA’s 2018 inspection, they indicated that they ceased operation, contracted again with a third-party cleaning service to conduct deep cleaning and sanitizing of their facility, made improvements to their production environment, and implemented (redacted) environmental monitoring. Furthermore, the agency had Regulatory Meetings with their firm in 2017 and 2019, to notify them of the FDA’s concerns with FDA inspectional findings, environmental findings, and the firm’s corrective actions. During both Regulatory Meetings, the firm committed to implementing corrective actions to prevent the recurrence of Listeria monocytogenes findings within their food manufacturing facility.

Given the history of findings, the FDA continues to be concerned about their ability to maintain a sanitary environment. The FDA recommends that they continue to identify potential harborage sites and source(s) of the organism in their processing environment and implement the necessary methods and controls to ensure Listeria monocytogenes does not contaminate their RTE food products. The FDA will verify the effectiveness of their corrective actions during their next inspection.

  1. The firm did not identify and evaluate whether there are hazards in their raw materials or other ingredients that require a supply-chain-applied control.

Their facility manufactures various RTE sandwich products using deli salad and deli meats as ingredients. These ingredients have the known or reasonably foreseeable hazard of pathogens including Listeria monocytogenes, and they do not receive any further processing in their facility to control these hazards. Thus, these hazards are controlled by their supplier. The need to consider the hazard of pathogens in their ingredients is illustrated by their recall in October 2019 of Lunch Box Chicken Salad Fresh Wedges, Lunch Box Chicken Salad Frozen Wedges, and Fresh and Local Chicken Salad Croissants because of the potential contamination of the chicken salad ingredient with Listeria monocytogenes. In their revised hazard analysis contained in their food safety plan included with their March 10, 2020, response, they did not identify the hazards in their incoming ingredients as needing a preventive control such as supply-chain-applied control. Although their revised food safety plan indicates the importance of (redacted) during shipment to their facility, this does not address the hazard of pathogens in incoming ingredients.

  1. The firm did not appropriately evaluate the hazard of bacterial growth and/or toxin formation based on the packaging of their food. Their hazard analysis, dated July 30, 2019, did not identify bacterial growth and/or toxin formation as a hazard requiring a preventive control based on the packaging of their food. Their revised hazard analysis contained in their food safety plan included with their March 10, 2020, response, acknowledges that “our sandwiches are (redacted) packaged which can create the growth of C. botulinum” but states that “We control this hazard by our (redacted) which does not allow C. botulinum to grow. Therefore, we feel that this does not need a PC.” It is not appropriate to conclude that a hazard does not need a preventive control based on the presence of such a control. They state that they control the hazard of C. botulinum by their (redacted); thus, this program is the preventive control for the hazard.
  2. The firm did not establish and implement adequate written verification procedures.
  • Their environmental monitoring procedures are not adequate. Specifically, their “Environmental Sampling-(redacted) & In-house,” dated Feb. 26, 2020, states that for their “(redacted)-Done (redacted)” they will “collect (redacted) swabs from different locations in our production room, place swabs and paperwork in cooler with ice pack, Ship to (redacted), place report in Environmental Sampling Book.” Additionally, for their “In House Testing-Done,” they will “collect (redacted) swabs from different locations in our production room, place in incubator, record results.” The firm’s environmental monitoring procedures for both their external laboratory analysis and in-house testing do not identify the locations from which samples will be collected and the number of sites to be tested during routine environmental monitoring; or identify the test(s) conducted.

The full warning letter can be viewed here.

Chicago Indoor Garden Inc.

Chicago, IL

A company in Chicago is on notice from the FDA for Produce Safety regulation violations, including the presence of E. coli O103 on sampled sprouts.

In a July 30 warning letter the FDA described a Feb. 28 through March 31, 2020, inspection at Chicago Indoor Garden Inc.’s sprouting operation. Inspectors found that the company had serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation 

FDA’s inspection resulted in issuance of an FDA Form 483. The significant violations are as follows:

Pathogen Findings

March 3, 2020 — The FDA collected a sample of red clover sprouts (1119371) from their sprouting operation. The laboratory analysis yielded E. coli O103 isolated from one of 10 swabs. Whole genome sequencing (WGS) analysis was conducted on the two E. coli O103 isolates obtained from the positive product sample collected during the FDA inspection on March 3, 2020. The WGS analysis determined that the two isolates from sample 1119371 were genetically identical to each other and to isolates from the outbreak (2002IAEXW-1 and 1912IAEXW-1).

The FDA received their written response on April 15, 2020, outlining the corrective actions that they have taken in response to the product sample findings; however, the FDA inspectors were unable to evaluate the adequacy of their corrective actions. The FDA acknowledges that they agreed on March 16, 2020, to recall all products containing red clover sprouts. The FDA also acknowledges that they stated that they stopped production of red clover sprouts, ordered seed from a different supplier, conducted a root cause analysis, had the seed’s spent irrigation water tested for E. coli O103, and deep cleaned some of the equipment that they use to grow their sprouts in. The FDA will evaluate the adequacy of their corrective actions at the FDA’s next inspection.

Produce Safety Regulation Violations

During the inspection, FDA investigators observed the following significant violation of the Produce Safety regulation:

  1. The firm did not discontinue the use of all seeds from a lot which they knew or had reason to believe may have been contaminated with a pathogen, and they did not ensure that sprouts grown from that lot of seeds did not enter commerce. Specifically, at the end of December 2019 and beginning of January 2020, their operation received communication from their seed supplier, indicating that sprouts grown from clover seed lot (redacted) had been voluntarily recalled by another sprouting operation, and that the seed supplier was waiting to receive test results to determine whether lot (redacted) was contaminated with pathogens. In December 2019, they placed that lot on hold. However, in January 2020, without further communication from their seed supplier, they resumed sprout production using lot (redacted) to grow sprouts which were sold to their customers.

The FDA acknowledges their written response received April 15, 2020; however, the FDA is unable to evaluate the adequacy of their corrective actions. In their response, the firm stated that decisions made about “questionable” seed would be discussed with the owner and all management before any decisions are made about that seed. The FDA will evaluate the adequacy of their corrective actions at the FDA’s next inspection.

  1. The firm did not inspect, maintain, and clean, and, when necessary and appropriate, sanitize all food contact surfaces of equipment and tools used in covered activities as frequently as reasonably necessary to protect against contamination of covered produce. Specifically, on March 10, 2020, and March 12, 2020, after the FDA investigator observed an employee cleaning sprout drums used in the growing of sprouts, the investigator observed that those sprout drums contained yellowish-brown residues on their walls, and the screw heads of the drums had black residues on them.

The full warning letter can be viewed here.

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