FDA Warning Letters Issued to Three Importers for Lack of FSVP - Nov 1 2022

Three importers were issued Warning Letters by FDA for lacking a FSVP for imported foods.

Facema, LLC. of Laurel, MD did not develop, maintain, and follow an FSVP, as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any imported foods, including the following food:  Tomato sauce (with other ingredients) imported from (b)(4), located in (b)(4);  Toffee candy imported from Facema S.A. de C.V. located in Nicaragua; and 
Peanuts imported from (b)(4) located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/facema-llc-640528-10182022

ARYZ Trading, LLC of  Dearborn, MI did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any of the foods imported, including each of the following foods:  Dried mint: imported from (b)(4)
Tahina: imported from (b)(4) Extra virgin olive oil: imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aryz-trading-llc-639322-09212022

Minuti Coffee Llc, of Houston, TXdid not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, did not develop an FSVP for any of the foods imported, including each of the following:  a. Hot Chocolate (Cioco Delice White Chocolate), imported from Caffe Molinari S.P.A., Via Francia 20, Modena, Modena, 41122, Italy b. Decaf Coffee and Vinegar, imported from Caffe Molinari SPA, Via Manfredo Fanti 200/206, Modena, Modena, 41122, Italy
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/minuti-coffee-llc-635961-08232022

FDA Warning Letter - NC Processor of RTE Product with Listeria Issue

FDA issues a Warning Letter to Bakkavor Foods facility in Charlotte, NC, a processor of ready-to-eat (RTE) dips, soups, salad bases, burritos, entrée style meals, and seafood products.

First, this company that processes RTE foods did not recognize environmental pathogens as a significant risk requiring a Preventive Control.  From the report, the" hazard analysis for “Ready to Eat Cold Salads, Sauces, Sides, and Dressings” at various processing steps (e.g., cold mixing, filling) determined that pathogens from “Environmental Cross-contamination” is a “Hazard Not Reasonably Likely To Occur due to lack of history with Food Contact Surface contamination with Listeria spp.” You also reference “Pre-Operational and Operational Sanitation Inspections” and “Good Manufacturing Practices” as “Control Measures in place.” Your sanitation inspections and GMPs are not preventive controls."

Indeed, FDA conducted environmental sampling and found Listeria.  Also of note, based upon WGS identification, the same strains had been found in the facility in 2019....an indication that this is a persistent strain.  

"To underscore the L. monocytogenes risk in your facility: FDA’s environmental findings indicate that you have a resident strain of L. monocytogenes in your facility, as well as transient strains.

FDA laboratory analysis of environmental sample 1171734 collected on February 8, 2022, from various areas in your processing facility, including food-contact surfaces and areas adjacent to food-contact surfaces, confirmed fourteen (14) of one-hundred ten (110) environmental swabs were positive for L. monocytogenes. These locations include areas where products are exposed to the environment prior to packaging in your production room, (b)(4) room, work in progress (WIP) cooler, and (b)(4) room. This was not the first time L. monocytogenes was found in environmental samples collected at your facility."

FDA noted that the company had been finding Listeria in their testing.  However, there was insufficient corrective action taken.

FDA goes on to state, "Given the history of our findings and the presence of L. monocytogenes in your facility, we continue to be concerned about your ability to maintain a sanitary environment. Your written responses did not fully explain how you investigated the source of the resident L. monocytogenes, demonstrate that you have located and eradicated the harborage site(s), or provide supporting documentation to show implementation and verification of adequate corrections (e.g., revised Food Safety Plan or routine environmental sampling results)."

GMP issues

• "Hose nozzles, used for rinsing RTE food contact equipment, stored on the floor: in the (b)(4) area, between the (b)(4) lines in the production room, next to a trash cart in the production room, and in the kettle room."
• "Excessive condensation on the ceiling and evaporators throughout your facility directly above RTE product and food-contact surfaces, including in the WIP cooler and over unprotected, cleaned, and sanitized RTE food-contact bins in the (b)(4) washroom. Also, condensation was observed on the ceiling above the (b)(4) hopper for the (b)(4) machine where RTE (b)(4) and (b)(4) are manufactured."
• "While walking across the floor of the WIP cooler, employees splashed pooled water onto trays of in-process RTE food (prior to packaging) stored on rolling racks in the cooler. The pooled water appeared dirty and contained food residue."
• "Apparent rust on the food-contact parts of the Cheese Grinder (b)(4) and its outlet port. They also observed that the (b)(4) on the (b)(4) tumblers which hold RTE food were damaged, making them difficult to clean."
• "Apparent food residue remaining on the inside cup holder framework of the (b)(4) machine where RTE (b)(4) and (b)(4) dip are packed, as well as on the conveyor belts and framework for (b)(4) lines (b)(4), after pre-op inspection and release by quality assurance "
• "Apparent old and fresh product and black residue on the wheels of the conveyors for the (b)(4) line and the (b)(4) lines after pre-operation inspection and release by quality assurance on February 10, 2022. The wheels contact the outer/food-contact surface of the belts."

There were also issues with the Seafood HACCP plan including temperature control issues with finished product.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bakkavor-foods-usa-inc-630545-08082022
Bakkavor Foods USA Inc.

Needing to Update The Environmental Sampling Program?

A recent article in Food Safety magazine ( FDA Environmental Monitoring Tactics Have Changed—Have Yours? Bryan Armentroutasks (2022)) asks if your Environmental Sampling Program can hold up to an FDA inspection's sampling regiment. It highlights aspects of the recently updated FDA Investigation Operational Manual - Chapter 4 - Sampling, specifically from this, Section 4.3.7.7.1 Environmental Sampling.

First, one should be aware and somewhat knowledgeable about the FDA Investigations Operations Manual (IOM) and within that, Chapter 4. Sampling.

The author of the Food Safety Magazine article points out keys of what FDA within their environmental sampling regiment may do that may be different than what a company's sampling plan may do.

• "They will not tell you that they are going to sample, until they are ready to start"
• "They are going to sample food contact and indirect contact surfaces"
• "They are not going to sample floors and drains"
• "They are going to sample during production, with a target of four hours of activity after a wet clean"
• "If a positive is found, they are sending it out for identification, adding it to the U.S. Centers for Disease Control and Prevention (CDC) database, and cross-referencing for any outstanding or past food safety incidents."

This does not mean that a company needs to do exactly what FDA does.  We certainly will maintain a focus on Zones 2 to 4 as a way of understanding contaminants with the facility, and focusing on preventing contamination from getting to food contact surfaces (Zone1).  But a company needs to know that Zone 1 is not contaminated and that contamination does not leak out into the facility once production is in full swing.

Selected items from 4.3.7.7.1
INVESTIGATIONS OPERATIONS MANUAL 2022 (https://www.fda.gov/media/75243/download)

4.3.7.7.1 - Environmental Sampling

• Every effort should be made to conduct Listeria sampling when the facility has been in production for at least four hours and before any wet cleaning is performed. In instances with smaller firms that have short production periods, swabbing should be conducted during the mid to tail end of their production schedule.
• In most cases, subsamples for Salmonella will be collected from the Zones 2 – 4 (see below), concentrating primarily on Zone 2. Samples should be collected from the equipment itself, particularly equipment mounting and support structures. When targeting Listeria, swabs will be collected primarily from Zones1 and 2. Perform most of the sampling for Listeria in, on, and around food contact equipment, focusing on areas where food is exposed and being processed, particularly post-treatment/pasteurization.
• A large majority of the environmental samples collected should be taken from Zones 1 (when directed and depending on the organism in question) and 2, and to a lesser degree Zone 3 areas. Very few, if any, environmental samples should be taken from Zone 4 areas.
• Swab subsample numbers for each organism are as follows:
• For Salmonella environmental swabbing, collect at least 100 swabs/subs and ideally 300 or more
• subs
• For Listeria environmental swabbing, collect at least 50 swabs/subs and ideally 100 or more subs.

Also, there can be samples taken for food samples.

Here are the FDA Zone definitions:

IL Restaurant Norovirus Outbreak with 173 Reported Ill

McHenry County Department of Health (IL) issued their investigative report into a Norovirus outbreak associated with 173 people becoming ill.

"It could not be determined during this outbreak investigation exactly how Norovirus was introduced into the food establishment. Typically, Norovirus is introduced into a food establishment through a contaminated food product or through an ill individual. The epidemiological investigation confirmed that there were multiple food items associated with illness, and multiple sources of illness. MCDH is also aware of Norovirus infection in the community at the time of the outbreak, through investigation of an unrelated, confirmed outbreak  of Norovirus at a local school. Therefore, the likelihood a food item was received at the food establishment already contaminated with Norovirus is low, and this is unlikely to be the source  of the outbreak."

https://www.mchenrycountyil.gov/home/showpublisheddocument/109263/638024843979870000
Acute Gastroenteritis (AGE) Outbreak:
D.C. Cobb’s
McHenry, Illinois
September 2022

Investigated by:
McHenry County Department of Health
2200 North Seminary Avenue
Woodstock, Illinois 6009

LA Establishment Recalls Cooked Chicken Breast Patty Product for Extraneous Clear Hard Plastic

Foster Farms, a Farmerville, La. establishment, is recalling approximately 148,000 pounds of fully cooked frozen chicken breast patty products that may be contaminated with extraneous materials, specifically hard clear pieces of plastic.  The problem was discovered when the firm notified FSIS that it received consumer complaints reporting hard clear plastic embedded in fully cooked, frozen, breaded chicken breast patty products with a best by date of Aug. 11, 2023.

https://www.fsis.usda.gov/recalls-alerts/foster-farms-recalls-fully-cooked-frozen-chicken-patty-products-due-possible-foreign
Foster Farms Recalls Fully Cooked Frozen Chicken Patty Products Due to Possible Foreign Matter Contamination

FSIS Announcement

WASHINGTON, Oct. 29, 2022 – Foster Farms, a Farmerville, La. establishment, is recalling approximately 148,000 pounds of fully cooked frozen chicken breast patty products that may be contaminated with extraneous materials, specifically hard clear pieces of plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

TX Establishment Recalls Meat-containing Potstickers That Were Repacked Without Inspection

JYC Enterprise, Inc., a Houston, Texas establishment, is recalling approximately 33,280 pounds of frozen chicken and pork potsticker products that were repackaged, relabeled, and distributed without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.  The problem was discovered during routine FSIS verification activities. FSIS determined that the firm repackaged and relabeled the potsticker products without the benefit of federal inspection.

Another instance of a company repackaging meat-containing products and not getting USDA-FSIS inspection.

https://www.fsis.usda.gov/recalls-alerts/jyc-enterprise-inc--recalls-chicken-and-pork-potsticker-products-produced-without
JYC Enterprise, Inc. Recalls Chicken and Pork Potsticker Products Produced Without Benefit of Inspection

FSIS Announcement
WASHINGTON, Oct. 28, 2022 – JYC Enterprise, Inc., a Houston, Texas establishment, is recalling approximately 33,280 pounds of frozen chicken and pork potsticker products that were repackaged, relabeled, and distributed without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Whole Foods Recalls Dipping Caramel for Undeclared Wheat

Whole Foods Market is voluntarily recalling Dipping Caramel from five stores in Colorado, Kansas, and Nebraska because the product may contain wheat, which is not declared on the product label.  The mislabeling issue was discovered by a store employee. No illnesses have been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/whole-foods-market-issues-allergy-alert-dipping-caramel-sold-five-stores-colorado-kansas-and
Whole Foods Market Issues Allergy Alert for Dipping Caramel Sold in Five Stores in Colorado, Kansas and Nebraska
Summary
Company Announcement Date:  October 27, 2022
FDA Publish Date:  October 27, 2022
Product Type: Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Whole Foods Market
Brand Name:  Whole Foods Market
Product Description:  Dipping caramel

FDA Updates on FSMA Inspections for FY22

FDA inspections are beginning to pick back up after a slow down during COVID pandemic.

Specialty Foods Association
https://www.specialtyfood.com/news/article/fda-reveals-fsma-experience-fspca-annual-conference/
10/26/2022

FDA Reveals FSMA Experience at Annual Conference

Author:  Ron Tanner

FDA Reveals FSMA Experience at Annual Conference

FDA has emerged from the pandemic with a renewed emphasis—and a new approach—to inspecting manufacturers for compliance with the Preventive Controls for Human Food regulations of the Food Safety Modernization Act and to inspecting importers to determine whether they are following the Foreign Supplier Verification Program.

“Our inspections are still ebbing and flowing but we are moving in the right direction,” said Glenn Bass, deputy director, human and animal food operations—west, Office of Regulatory Affairs, FDA, during last week's Food Safety Preventive Controls Alliance Annual Conference. “We continue to rethink our field activities based on what we learned during the pandemic.”

FDA Issue Warning Letter to Spice Repacker

FDA issued a Warning Letter to El Gordo Spices of Dallas TX,  where herbs, spice, and seafood are repacked and warehoused.  During our inspection, FDA investigators found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation - failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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)]. Based on the inspectional findings, the shelf stable ready-to-eat (RTE) Whole Dried Shrimp and Ground Dried Shrimp were found to be adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

Further, FDA reviewed labels of repacked products (Ground Dried Shrimp, Whole Dried Shrimp, Sesame Seeds, Textured Soybeans, Ground Cumin, and Whole Bay Leaves) and found serious violations of the Food Labeling regulation.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/el-gordo-spices-llc-639957-09302022
WARNING LETTER

El Gordo Spices, LLC
MARCS-CMS 639957 — SEPTEMBER 30, 2022