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

Cornbread Dressing Product Recalled Due to Use of Recalled Eggs as Ingredient

Savannah Food Company, Inc., in a huge abundance of caution,  is recalling certain formulations of Cornbread Dressing and Bread Stuffing that included frozen diced eggs supplied to our company by Almark Foods, which were recalled due to Listeria.

With fully cook instructions on the cornbread dressing boxes, risk would be minimal.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/savannah-food-company-inc-voluntarily-recalls-cornbread-dressing-and-bread-stuffing-products-due
Savannah Food Company, Inc. Voluntarily Recalls Cornbread Dressing and Bread Stuffing Products Due to Possible Health Risk
Summary
Company Announcement Date: January 21, 2020
FDA Publish Date: January 23, 2020
Product Type: Food & Beverages  Prepared Food
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name: Savannah Food Company, Inc.
Brand Name:  Morrison’s, Savannah Classics, Piccadilly
Product Description:  Cornbread Dressing and Bread Stuffing

Sandwich Company Expands Recall Again

Lipari Foods is yet again expanding its recall of Premo and Fresh Grab sandwiches due to potential contamination of Listeria monocytogenes.  The issue started when their supplier notified them. The initial recall was on January 6, 2020 and second on January 13, 2020 . 

This is a typical type of a scenario where a company finds that they never had Listeria under control.  They may have not had a sufficiently robust program to find it....doing testing, but not really looking for it.  Hard to say for sure what occurred, but further expansion of a recall is never what you want to see.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lipari-foods-issues-voluntary-recall-expansion-additional-sandwiches-due-potential-contamination-0
Lipari Foods Issues Voluntary Recall Expansion on Additional Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Summary
Company Announcement Date: January 22, 2020 

FDA Publish Date: January 22, 2020 

Product Type:Food & Beverages Prepared Food Foodborne Illness 

Reason for Announcement:  Due to potential contamination of Listeria monocytogenes

Company Name:Lipari Foods

Brand Name:  Premo, Fresh Grab

Product Description:  Sandwiches

More Tahina Recalled After Michigan Ag Finds Salmonella in Product

A Michigan company is recalling tahina (tahini) after the Michigan Dept of Ag tested and found product positive for Salmonella.  No illnesses have been reported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/five-star-food-recalls-sham-gardens-excellent-tahina-because-possible-health-risk
Five Star Food Recalls Sham Gardens Excellent Tahina Because of Possible Health Risk
Summary
Company Announcement Date: January 15, 2020 

FDA Publish Date: January 21, 2020 

Product Type: Food & Beverages
Reason for Announcement:Foodborne Illness  Potential to be contaminated with Salmonella
Company Name: Five Star Food Inc. 

Brand Name: Sham Gardens
Product Description:  Tahina

Michigan Processor Agrees to Stop Production After Unable to Control Listeria

A Michigan food processor agreed to suspend operations after years of not being able to get compliant with regulation.   Home Style Foods of  Hamtramck, MI, a manufacturer of ready-to-eat seafood and deli salads, failed to get take sufficient corrective actions to get their Listeria monocytognes issues under control.  From the notice:

"According to the complaint filed with the consent decree, the FDA inspected the facility seven times between May 2009 and June 2018. During each inspection, the FDA investigators observed significant objectionable conditions. The FDA also found L. mono in the facility in two of the inspections, including the most recent inspection. The company was issued an FDA Form 483 after each of the seven inspections, was issued a warning letter in April 2016 and the company attended a regulatory meeting with the FDA in January 2017. The defendants repeatedly promised to take corrective actions to address the objectionable conditions. However, the FDA’s June 2018 inspection showed that the defendants have failed to take effective measures to bring Home Style Foods’ ready-to-eat food processing operations into compliance with the law."

FDA News Release
https://www.fda.gov/news-events/press-announcements/michigan-based-food-manufacturer-agrees-stop-production-after-repeated-food-safety-violations
Michigan-based food manufacturer agrees to stop production after repeated food safety violations
For Immediate Release:January 13, 2020

Sandwich Recall for Listeria Expanded

Lipari Foods expanded their recall of Premo and Fresh Grab sandwiches due to the potential for Listeria monocytogenes.  The recall comes after the supplier of those sandwiches, JLM Manufacturing expanded their recall.  The recall was initially made after environmental sampling returned a positive test result for Listeria monocytogenes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lipari-foods-issues-voluntary-recall-expansion-additional-sandwiches-due-potential-contamination
Lipari Foods Issues Voluntary Recall Expansion on Additional Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Summary
Company Announcement Date: January 13, 2020
FDA Publish Date: January 13, 2020
Product Type: Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name: Lipari Foods, LLC
Brand Name:  Premo,& Fresh Grab
Product Description:  Sandwiches

FDA Warning Letter to RTE Salad Processor

FDA issued a Warning Letter to a RTE Salad company after FDA's inspection found Listeria in the processing environment.  Accordingly, FDA's Warning Letter states that the facility's Preventive Control plan is not adequate.  They  did "not identify and implement a preventive control adequate to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes from contaminating RTE produce in your facility".  Further, "did not implement your preventive control to prevent cross-contamination during washing. "

The validation of their process was also off the mark.   The facility "did not properly validate your preventive control for the use of (b)(4) to prevent cross-contamination. The study presented by your firm is titled “EPA Food Contact Sanitizer Test for Previously Cleaned Food Contact Surfaces (AOAC Germicidal and Detergent Sanitizing Action of Disinfectant) against Salmonella choleraesuis and Listeria monocytogenes.” That study pertains to food contact surfaces and was not designed to validate, nor is it adequate to validate, the antimicrobial efficacy of peracetic acid against pathogen cross-contamination during the produce washing process."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/country-fresh-inc-591206-12122019
FDA WARNING LETTER
Country Fresh Inc.
MARCS-CMS 591206 — December 12, 2019

E.coli Outbreaks Linked to Salinas Romaine Declared Over, Investigation Continues

The FDA is lifting the consumer advisory to avoid romaine lettuce from Salinas growing region.  This is both E.coli outbreaks, one for the Romaine lettuce outbreak as well as the chopped Salad Kits.

"The FDA and CDC have been tracking two multi-state romaine lettuce outbreaks. Today, federal health officials are declaring both multi-state romaine lettuce outbreaks over. One of the outbreaks sickened 167 people in 27 states. The other outbreak, linked to Fresh Express salad kits, sickened 10 people in five states."

However, little has been determined on how the contamination events occurred.   The investigation continues.


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-romaine-salinas-california-november-2019
Outbreak Investigation of E. coli: Romaine from Salinas, California (November 2019)
Outbreak appears over; FDA investigation efforts continue

January 15, 2020

Recommendation

As of January 15, 2020, the CDC reports that the outbreak appears to be over. Contaminated romaine from the Salinas, CA growing region that made people sick in this outbreak is likely no longer available. Consumers need not avoid romaine lettuce, or any other produce, from the Salinas, CA growing area.

Case Counts

Total Illnesses: 167

 Hospitalizations: 85

 Deaths: 0

 Last illness onset: December 21, 2019

 States with Cases:  AZ (4), CA (8), CO (6), DE (1), FL (4), IA (1), ID (4), IL (15), MD (5), MI (2), MN (7), MT (1), NE (2), NJ (9), NC (3), NM (2), NY (3), OH (12), OR (1), PA (21), SC (1), SD (1), TN (1), TX (6), VA (6), WA (6), WI (35)

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-salad-mix-december-2019
Outbreak Investigation of E. coli: Salad Mix (December 2019)
Outbreak linked to Fresh Express brand Sunflower Crisp Chopped Salad Kits appears over
January 15, 2020

Recommendation

As of January 15, 2020, the CDC reports that the outbreak appears to be over.
Contaminated Fresh Express Sunflower Crisp Chopped salad kits that made people sick in this outbreak are likely no longer available on the market.

BPA Substitute in BPA-free Containers May Have Similar Concerns

A study out of the University of Guelph shows that a BPA-replacement chemical used in food packaging, named BPS or Bisphenol S may have similar effects to BPA.

BPA is a chemical used in plastic package manufacturing and there has been scrutiny of this chemical and its impact on health.  BPA has been eliminated from plastic used for baby bottle manufacturing.
"Because of the concern about its potential toxicity in humans, BPA is increasingly replaced by structurally similar chemicals, in particular bisphenol F (BPF) (4,4′-dihydroxydiphenyl-methane) and bisphenol S (BPS) (4,4′-sulfonylbisphenol), in the manufacturing of polycarbonates and epoxy resins."  However, surveys of urinary levels show that BPS is almost ubiquitous. {Lehmler, etal 2018] 

So BPA-free may not be much different than containers with BPA for those looking to avoid the packaging additive.

https://news.uoguelph.ca/2020/01/bpa-replacement-hinders-heart-function-u-of-g-study-reveals/
BPA Replacement Hinders Heart Function, U of G Study Reveals
Wednesday, January 8, 2020
BPA’s counterpart replacement BPS can hinder heart function within minutes of a single exposure, according to a new University of Guelph study.