New York Importer Receives Warning Letter from FDA for FSVP Noncompliance

FDA issued a Warning Letter to IMAD International, LLC Bronx, New York after a remote Foreign Supplier Verification Program (FSVP) inspection as well as an inspection on April 18, 2019.  FDA found that this firm was not in compliance with the Foreign Supplier Verification Program (FSVP) regulations by not having a program for the suppliers in which product was purchased.


FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/imad-international-llc-613268-03292021
IMAD International, LLC
MARCS-CMS 613268 — MARCH 29, 2021

FDA Warning Letter Issued to Texas Importer of Frozen Sliced Strawberries for Lack of FVSP

A Texas based importer was issued a Warning Letter by FDA for not being in compliance with the  FSVP requirements for Frozen Sliced Strawberries   The company had not identified or evaluated biological, chemical or physical hazards potentially present before your suppliers load the products.  There were no established  and written procedures to ensure that  import foods only come from foreign suppliers previously approved based on evaluation conducted to determine a foreign supplier’s performance and the risk posed by the food,  The company did not establish and follow written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the imported foods.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/campimex-inc-610730-12112020
Campimex, Inc.
MARCS-CMS 610730 — December 11, 2020 

FDA Issues Warning Letters to Three Food Importers for FSVP Issues

FDA issued Warning Letters to three food importers for issues involving the Foreign Supplier Verification Program (FSVP).  Two of these were remote audits.

• E & H Distributors LLC of , San Diego, CA  did not have FSVPs for soft tamarind flavored candy from one supplier and candy imported from another foreign supplier.
• World Candy Store LLC, of Brownsville, Texas 78521. did not have FSVPs for these products, Ricolino Huevito Pinto imported from foreign supplier (b)(4), and Ricolino Huevito imported from foreign supplier (b)(4). 
• WCS Trading Inc, of  Los Angeles, CA 90032 did not complete a review of the supplier's hazard analysis and did not perform verification activities for dried crushed chili, dried black fungus and dried mushrooms

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eh-distributors-llc-610883-11042020
E&H Distributors LLC
MARCS-CMS 610883 — November 04, 2020 

FDA Issues Warning Letters to Two Importers for Lack of FSVP

FDA issued Warning Letters to two different companies for FSVP.  Neither company had a FSVP in place.

• Italfoods, Inc., of South San Francisco, CA did not have it in place for cheese products improted from Italy including Pecorino Toscano DOP Stagionato cheese, your Pecorino Cacio Di Bosco Tartufo Stagio cheese, and your Pecorino Brillo Formaggio cheese.  One of the products had been found to have Listeria monocytogenes contamination.
• Handylee USA Corp. of Maspeth, NY did not have FVSP for imported canned corn. canned mushrooms and canned bamboo.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/italfoods-inc-610183-10272020
Italfoods, Inc.
MARCS-CMS 610183 — October 27, 2020 

FDA Warning Letters Issued to Importers for Non-compliance to FSVP

FDA issued Warning Letters to four importers for not have Foreign Supplier Verification Programs in place for the food items these companies were importing. FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.


Martinez Mexican Produce, LLC, at 1704 N. International Blvd., Hidalgo, TX 78557.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/martinez-mexican-produce-llc-607645-06162020

Fides New York Inc. located at 4725 208th Street, Bayside, NY 11361-3214
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fides-ny-inc-608989-07292020

Gourmet and More, Inc. located at 2976 Alvarado St., Ste D, San Leandro, CA 94577.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gourmet-more-608887-07312020

Grupo RM USA, Inc., located at 7991 NW 82nd Ave. Miami, FL 33166.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grupo-rm-usa-inc-609291-08062020

FDA Warning Letters - Three Importers Issued Warning Letters for Not Having FSVP

In the weekly listing of Warning Letters, FDA had issued Warning Letters to three food importers for not having FSVP (Foreign Supplier Verification Programs in place for items that were being imported into the US.  "The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards."   This includes conducting a hazard analysis on each imported item from a supplier, determining if there are any significant risks, and then implementing controls for risks that are being controlled by the supplier.

1. Pasha Food Distribution USA, Inc.,of Chatsworth, California did not have a FSVP for roasted eggplant product, dried sumac and tahini products.  The company also did not register the facility as required.
2. Kaymile Trading, Inc.of South El Monte, California did not develop, maintain, and follow an FSVP fir the following items - Roasted onion granules and coarse black pepper
3. Ventura Terra Garden Inc., of  Ventura, CA was not in compliance for fresh packaged enoki mushrooms.

FDA Issues Warning Letters to Three Firms for Non-compliance for FSVP for Imported Goods

FDA issued Warning Letters to three firms for not being in compliance with the FSVP regulations.  These firms did not have FSVP in place for products they imported.

Global Commodities Corp., of  Hayward, CA 94545 was not in compliance with the FSVP  for Buenas Kaong Red Sugar Palm Fruit in Syrup and Macapuno String in Syrup preserves imported from (b)(4), Philippines; and Boy Bawang Mixed Nuts Snacks – Garlic imported from KSK Food Products, Philippines. The firm did not have FSVPs for these products.

H & C Food Inc., located at 1300 Metropolitan Ave, Brooklyn, NY was found not to be in compliance with the FSVP requirements for  Enoki Mushroom imported from Green Co., Ltd, South Korea and Teriyaki Kimnori Roasted seaweed Snack (b)(4). The firm did not have FSVPs for these products. 

Diamond Rock Food Imports, Inc.of Copiague, NY was not in compliance with the requirements of FSVP regulations for Tomato Sauce and Refried Red Beans products imported from (b)(4) and the Grape Soft Drink product imported from your (b)(4). The firm did not have an FSVP for these products or any other products imported by your firm.

FDA Warning Letter - Another Importer Without a FSVP Program for Their Imported Food Items

FDA issued a Warning Letter to Mission, LLC of, Renton, WAS for not have a FSVP (Foreign Supplier Verification Program) in place for the food items that the company was importing.  Specifically, they did not have a FSVP for imported black tea.  As part of this analysis, the company would conduct a hazard analysis on this item and determine if any of the hazards are significant, requiring control by their supplier.

WARNING LETTER
Mission LLC
MARCS-CMS 593118 — February 06, 2020

Two Importers Issued Warning Letters for Not Having FSVP

Two importers were issued Warning Letters by FDA for not having FSVP programs.  FDA is focusing more enforcement attention on food importers with the requirement for having a foreign supplier verification program (FSVP) as required as part of the FSMA regulation, specifically  21 CFR part 1 subpart.

Swagath Home Foods LLC of WA did not have FSVPs for for Black Pepper Powder imported from Subhash Masala Co. Pvt. Ltd., Spiced Chutney Powder imported from MTR Foods Pvt. Ltd., and Potato Chips imported from Pepsico India Holding Pvt.

Dinamix Distribution, LLC, was TX was not in compliance with the requirements of 21 CFR part 1 subpart L - did not have FSVPs for the following imported products: mayonnaise; tomatoes-spice flavored drink; and punch flavored soft drinks imported from (b)(4).

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swagath-home-foods-llc-594166-01072020
Swagath Home Foods LLC 
MARCS-CMS 594166 — January 07, 2020

FDA Warning Letter - Bakery Supply Company with No FSVP in Place for Their Imported Food Items

FDA issued a Warning Letter to a bakery supply company for not having a Foreign Supplier Verification Program (FSVP) for items that they are importing and then selling.  These items include multi-color sprinkles, Strawberry filling, and Bavarian cream.

Companies who import products must have assurances that food made overseas meets US standards.  For those who are importing and reselling that food in the US, whether that food will be sold without further processing (sold as-is) or sold to a company who will use it as an ingredient in food they process (such as in the case here), that importer must have a FSVP in place for all items / each supplier in place.

It is important for companies who are using imported ingredients purchased from a US broker / importer, that they know that importer / broker does indeed comply with the FSVP rule.

It's also good to know if the items you use are imported.  One could guess that few question whether their multi-colored sprinkles are imported.  And it's not like someone is sourcing imported sprinkles like choosing imported fine wines...ah yes, I use only the Châteauneuf-du-Pape sprinkles please.  Or that the sprinkles can only be sourced from some exotic location...there is no Juan Valdez trekking up into the Andes to pick them from the scarce Jimmy trees.  So where do your sprinkles come from?

Is it a big deal?  From risk perspective, as an RTE item, we would want to have knowledge that the items must meet US standards for safety, including measures that prevent cross-contamination.  The FVSP Rule requires importers to evaluate the hazards of the items and ensure necessary controls are in place.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/el-molino-bakery-supplies-inc-593693-12162019
FDA WARNING LETTER 

El Molino Bakery Supplies Inc
MARCS-CMS 593693 — December 16, 2019

FDA Issues First Warning Letter to Company on FSVP Requirements

FDA issued a Warning Letter to an importer that had imported tahini product that was linked to 6 cases of Salmonella infection  in June of 2019.  This was the first warning letter regarding FSVP (Foreign Supplier Verification Program) requirements as part of FDA's FSMA regulation.

The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.  This means that importer must have proof that the foreign processor has a Preventive Control Plan and can successfully controlled potential hazards.  In the case of tahini, the supplier must have process and environmental controls to prevent contamination from Salmonella.

In this report, FDA found that the firm had not developed an FSVP for sesame paste tahini manufactured by their supplier Karawan Tahini and Halva in the West Bank, but even more of an issue was that the firm was not familiar with FSVP requirements.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/brodt-zenatti-holdings-llc-583679-07302019
FDA Warning Letter
Brodt Zenatti Holdings LLC
MARCS-CMS 583679 — Jul 30, 2019

Imported Foods and the FSMA Foreign Verification Program Rule (FSVP)

The Food Safety Modernization Act (FSMA), signed into law in 2011, was designed to improve public health by strengthening the food safety system. The law provided authority to the U.S. Food and Drug Administration (FDA) to write and enforce regulations that focus on preventing food safety issues. The law also directs FDA to enforce food safety standards for foods imported from other countries, with the intent that these foods meet the same safety standards as those grown or processed in the U.S. FDA regulated foods that are grown, manufactured, or processed outside the U.S. are therefore covered under several FSMA regulations including the Produce Safety Rule, the Preventive Controls for Human Foods Rule, and the Preventive Controls for Animal Foods Rule. The Foreign Verification Program Rule (FSVP) requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.

One of the first challenges for food importers is determining if a particular food falls under FSMA or is excluded. There are many foods imported into the U.S. that may be excluded from FSMA coverage because pre-existing regulation are already in place. These include foods regulated under previously enacted FDA regulations for seafood and juice products. Foods that fall under USDA jurisdiction, specifically meat and poultry products, are excluded because USDA has established its own import regulations. There are also exclusions for imported foods that will not be consumed in the U.S., as well as foods imported solely for test purposes. A general rule to remember is that if a food that is not excluded, it will fall under one or more of the FSMA rules.

A key point for importers to understand is that all foods that are brought into the U.S., and then consumed in the US, must meet U.S. food safety standards. This means that fresh fruits and vegetables grown in another country for export to the U.S. must be grown, harvested, packed, and held under the standards established in the Produce Safety Rule. Foods (human or animal) or food ingredients imported into the U.S. for further processing by U.S. manufacturers will fall under the food safety requirements written in the Preventive Controls Rule for Human Foods or the similar rule for animals food. Imported foods that will not be processed by the importer such as those directly sold through retail entities must assume responsibility, in conjunction with their foreign supplier for the safety the product by developing a plan by to ensure that the safety of the product is properly controlled by the foreign supplier. It is the importer’s responsibility to understand the requirements of this rule and implement necessary measures to ensure that their foreign supplier has adequate food safety controls in place.

In some cases, the determination of who the importer is is not easy. Imported foods may by touched by a number of different entities as they make their way into the U.S. The key part of the regulation is to make sure that the importer is identified before the food enters the U.S. FDA requires this in order to assign responsibility for the imported product to that entity. This responsible entity must have a U.S. address where the proper documentation will be kept.

The designated FSVP importer is required, through development of a hazard analysis, to determine what potential hazards, if any, represent a potential risk for the given imported food. For those identified hazards having significant potential risk, the importer must ensure, or verify, that the foreign supplier has adequate controls to prevent or eliminate that risk. As a means of verification, importers can use one or more ways, including implementing testing requirements, conducting food safety audits, and collecting pertinent documentation. Verification must take place beforehand as part of a supplier approval process, and then monitored on an ongoing basis.

Individuals tasked with writing and implementing an a Foreign Supplier Verification Program must be qualified through training to do the task. This can be accomplished through attending a FSVP training course developed by the Food Safety and Preventive Control Alliance (FSPCA) and which is offered by Penn State. This training is not just necessary for those who import foods and therefore must write a FSVP plan. It is also important for U.S. food processors, retailers, and other food businesses who buy food from foreign sources; because in the end, they will also pay a price for a foreign supplier’s inadequate food safety program.

As you can see, the FSVP is complex and requires training to understand how the rule could affect your food operation. Visit the Penn State Extension FSMA website at extension.psu.edu/fsma for more information on the FSVP Rule and when and where Penn State will be offering training.

Links.
Registration site for the Penn State Foreign Supplier Verification Workshop
https://extension.psu.edu/foreign-supplier-verification-workshop

FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm