FDA sends warning letters to companies with foreign supplier and sanitation violations

FDA sends warning letters to companies with foreign supplier and sanitation violations

by Sue Jones
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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. The FDA frequently redacts parts of warning letters posted for public view.


WCS Trading Inc., Los Angeles
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In an Oct. 8 warning letter, the FDA described a May 14-26, 2020, Foreign Supplier Verification Program (FSVP) inspection at WCS Trading 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 firm’s significant violations of the FSVP regulation are as follows:

  1. The firm did not meet the requirement to review another entity’s hazard analysis to determine whether there are any hazards requiring a control. Specifically, on June 8, 2020, the firm consultant submitted HACCP plans for their dried black fungus and dried mushrooms imported from (redacted); and dried chili products (crushed, whole, and ring) imported from (redacted). They did not document their review and assessment of the hazard analyses conducted by their consultant.
  2. The firm did not meet the requirement to evaluate their foreign supplier’s performance for the products they import. Specifically, for their dried black fungus and dried mushrooms imported from (redacted) located (redacted), they provided their “procedures for evaluating vendors” and a corresponding “Vendor Assessment Form” for a different supplier, (redacted). However, the firm did not provide documentation of their evaluation of their supplier (redacted).
  3. The firm did not meet the requirements to perform foreign supplier verification activities for the products they import, including establishing written procedures for ensuring that appropriate supplier verification activities are conducted and documenting their determination of the appropriate supplier verification activity. Specifically, they did not document their determination or performance of appropriate supplier verification activities for their crushed chili products imported from (redacted) located in (redacted) or their dried mushrooms and dried black fungus imported from (redacted) located in (redacted)

The full warning letter can be viewed here.

World Candy Store LLC, Brownsville, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In an Nov. 3 warning letter, the FDA described a Sept. 3- 11, 2020, Foreign Supplier Verification Program (FSVP) inspection at World Candy Store 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 firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for any of the following food products:

  • Ricolino Huevito Pinto imported from (redacted)
  • Ricolino Huevito imported from (redacted)

The full warning letter can be viewed here.

E&H Distributors LLC, San Ysidro, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In an Nov. 4 warning letter, the FDA described a May 5 through Aug. 4, 2020, remote Foreign Supplier Verification Program (FSVP) inspection for their firm E & H Distributors 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 firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for any of the following food products:

  • (Redacted) soft tamarind flavored candy imported from (redacted)
  • (Redacted) candy imported from (redacted)

The full warning letter can be viewed here.

Etai’s Food Inc., Denver
A food firm in Colorado is on notice from the FDA because of insanitary conditions inside its manufacturing facility. The firm manufactures ready-to-eat (RTE) food products which include salads, sandwiches, burritos, wraps, pastas, and snacks. 

In a Nov. 4 warning letter, the FDA described a May 5 through Aug. 4, 2020, an inspection of Etai’s Food, Inc.’s manufacturing facility. The FDA’s inspection revealed that the firm was not in compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulations. As a result, the FDA issued an FDA Form 483.

Serious violations:

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

  1. The firm did not implement their procedures for environmental monitoring.
  2. Their Environmental Monitoring Program (dated October 9, 2019) states under “Routine Monitoring Frequency” that “(redacted)” and “(redacted).” However, their records revealed their firm did not monitor at this frequency. Specifically, in a 31-week period from July 2019 to Jan. 2020, their firm only conducted environmental swabbing (redacted) times. Additionally, their records do not indicate whether the swabs were collected (redacted) or (redacted) production.

Further, between July 30, 2019 and Oct. 1, 2019, (redacted) of (redacted)%) environmental swabs analyzed for Listeria spp. were found to be “indeterminate” by their third-party laboratory. The firm’s Environmental Monitoring Program only includes corrective actions procedures for “presumptive positive generic Listeria or Salmonella” findings and does not include corrective action procedures to address “indeterminate” results. Review of their documentation found that they did not take any corrective actions when “indeterminate” results were obtained. The FDA has concerns based on these results (including the frequency of “indeterminate” results) and their lack of subsequent action that their procedures are not adequate to verify that their sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazard of environmental pathogens.

  1. The firm Environmental Monitoring Program states that they will “Identify and Maintain a Master Site List” in which they will identify locations from which samples will be collected. During our inspection, the form’s Document Control Specialist stated they have not established their “Master Site List” and have not implemented their procedural step requiring selection of the sites from the “Master Site List.”

The firm’s response included a Master Site List with locations where environmental swabs should be collected. Additionally, they indicate that they are currently updating their Environmental Monitoring Program to include corrective actions to address “indeterminate” findings. However, they did not provide a copy of their revised Environmental Monitoring Program or copies of their records showing its implementation. The FDA will verify any implementation of a revised environmental monitoring plan during the FDA’s next inspection.

Supply-Chain Program (Subpart G)

  1. The firm did not implement a risk-based supply-chain program for those raw materials and other ingredients for which they have identified a hazard needing a supply-chain-applied control.

Their facility manufactures various RTE food products which use raw materials and ingredients that have a known or reasonably foreseeable hazard of pathogens that require a preventive control at the receiving steps, including “Receiving Dry/Shelf Stable Ingredients Roasted-Walnuts” and “Receiving Refrigerated Ingredients – Fresh Basil and Garlic,” and they do not receive any further processing in their facility to control these hazards. Thus, these hazards are controlled by their supplier. The firm’s supply-chain program, “Supplier Management Program-Approved Supplier Program,” dated October 9, 2019, establishes criteria for approving suppliers for their raw materials and ingredients. Their program requires that their suppliers provide responses to their supplier approval packet, a 3rd party audit, agreed specifications including lot code traceability information (or lot code description), and a Letter of Guarantee/Certificate of Conformance (COC). On February 13, 2020, we reviewed their documentation and records for the receipt of raw ingredients used in their pesto product. The firm did not have responses to their supplier approval packet, a 3rd party audit, specifications including lot code traceability information (or lot code description), and a Letter of Guarantee/Certificate of Conformance (COC) from their suppliers for basil and walnuts, as required by their supply-chain program.

The firm’s responses include a list of approved suppliers and indicate that they developed a questionnaire to send to their approved suppliers, developed a form to evaluate their suppliers, and are in the process of reviewing and implementing their Supplier Management Program. However, the firm did not include supporting documentation to show that they have obtained the documentation from suppliers required by their Supplier Management Program.

During FDA’s previous two inspections and during the FDA’s January 2018 and June 2019 Regulatory Meetings, the firm was made aware of the requirement to establish and implement a supply-chain program to control hazards associated with incoming raw materials and ingredients that they do not control in their facility. Their past corrective actions have indicated that they will begin to qualify their suppliers and implement a supplier management program. The FDA continues to be concerned about their ability to establish and implement an adequate supply-chain program. The FDA will verify the effectiveness of their corrective actions during the FDA’s next inspection.

Current Good Manufacturing Practice (Subpart B)

  1. All persons working in direct contact with food, food-contact surfaces, and food packaging-materials did not conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food.
  2. An employee was observed, while hand mixing RTE tuna salad, using their gloved hands to pick up containers of salad ingredients and then touch a soiled utility cart without changing gloves or washing their hands. Additionally, while (redacted) mixing the RTE tuna salad, portions of the employee’s exposed skin came into direct contact with the in-process product.
  3. An employee was observed touching objects in the production room/kitchen environment and then using their gloved hands as a scraper to transfer blended RTE pesto from a mixing container to a storage tub without changing gloves or washing their hands.
  4. After disposing of trash outside the building, an employee was observed returning to the RTE production room wearing the same gloves and then touching their clean smock, interior kitchen doors, and equipment without changing gloves and washing their hands.
  5. The firm did not clean and sanitize equipment in a manner that protects against contamination of food-contact surfaces. Specifically, an employee was observed, after preparing raw marinated chicken pieces, using a cloth towel to clean the stainless-steel preparation table and then using the same cloth to wipe sanitizer from the table.
  6. The firm did not take effective measures to protect finished food from allergen cross-contact and from contamination. Specifically, an employee was observed using a (redacted) hose to spray the floor and soiled equipment, causing splash-back on exposed clean food containers, trays, and bins which are used to store RTE food.

In addition to the violations described above, the FDA offered the following comments regarding their Allergen Management procedures:

  • Section 4.2 (“Change-over Protocols”) of their Allergen Management procedures states that if an “(redacted).” Additionally, their procedures state that an “Allergen Changeover Form” will be completed “to document that the changeover was completed properly,” a “(redacted) will be used by the changeover team,” and their QA will verify and document the completion of this process on form “Etai’s Sandwich Station Allergen Clean-up.” However, during FDA inspection they observed that their “Change-over Protocols” were not being fully implemented. Specifically, on January 23, 2020, February 11-13, 2020, and February 16-17, 2020, the facility manufactured various products with different allergen profiles on the same day and on shared equipment but did not document the results of the (redacted).
  • Section 4.6 (“Allergen Receiving and Storage”) of their Allergen Management procedures states that “(redacted).” However, during FDA inspection they observed the following:

    o Cheese cubes (milk allergen) were stored above an open container of mandarin oranges, and cheese crumbles had fallen into the mandarin oranges. These mandarin oranges are placed directly into finished product meal packages.

    o In Cooler (redacted), egg salad (egg allergen) was stored above a bin of shredded cheese on a wire rack labeled with a placard “egg/huevo,” and a tub of tuna salad was stored on top of a bin labeled “potato salad” in the same cooler.

    o Containers of walnuts and cashews were stored on a wire rack directly above an open box of red onions on a pallet in the warehouse.

The full warning letter can be viewed here.

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