FDA Warning Letter - NY Chocolate Company

FDA issued a Warning Letter to Maribel's Sweets, Inc. of Brooklyn, a manufacturer of Ready-to-Eat (RTE) chocolate products (including chocolate bars, ganache, hot chocolate, and cookies), and repacker of chocolate products.

FDA "determined that the RTE chocolate products manufactured in [the] facility are 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule."

Regarding the Preventive Control Plan
1) The company "did not prepare, or have prepared, and implement a food safety plan as required" by regulation.
2) Did not conduct a hazard analysis which would include identifying Salmonella, mycotoxins, and allergens as hazards of concern, and with that, appropriate controls were not identified.

Regarding GMPs

1) The facility was in poor shape including having cracks in the floor and peeling paint

2) Inadequate cleaning

3) Inadequate controls for allergens

4) Poor personal hygiene practices 

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maribels-sweets-inc-616288-10252021
Maribel's Sweets, Inc.
MARCS-CMS 616288 — OCTOBER 25, 2021

Longtime Penn State Short Course Contributor, Richard Kammerling, Passes

We were saddened to learn that Richard Kammerling, pest control expert and an instructor for Penn State's Food Safety and Sanitation Short Course, passed away this month.   In his presentations, he stressed being accountable for pest management systems and preparing for the unexpected.  With a lifetime of experiences, he made the topic of Pest Control exciting.  Many will not only remember Richard for his outstanding presentations on pest control management, but for his humor and friendly manner.  He loved to give people the 'business', especially the rest of the Penn State Food Science instructors.   He will be missed.

https://www.legacy.com/us/obituaries/newsday/name/richard-kammerling-obituary?id=31647824

Always, the last slide of his presentation.......

DON'T TAKE SHORTCUTS!

Bread Recalled After Packaged Incorrectly Resulting in Undeclared Sesame

Calise & Sons Bakery, Inc. of Lincoln RI is recalling bread packaged in the wrong bread bag.  The company produced Italian Scala Bread (Italian bread w/Sesame Seeds) and by error were packaged in a bag that says Golden Flax Seed Scala Bread, photos below. A total of 689 packages were produced that went out to markets in RI, MA, NH and CT.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/calise-sons-bakery-inc-recalls-golden-flax-scala-bread-because-possible-health-risk
Calise & Sons Bakery, Inc. Recalls Golden Flax Scala Bread Because of Possible Health Risk
Summary
Company Announcement Date:  November 24, 2021
FDA Publish Date:  November 29, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared sesame seeds
Company Name:  Calise Bakery
Brand Name:  Calise Bakery
Product Description:   Golden Flax Seed Scala Bread

Broccoli Tots Recalled for Rocks and Metal

Conagra Brands, Inc. (NYSE: CAG), is voluntarily recalling Birds Eye Broccoli Tots in 12 ounce packages with specific best buy dates due to the potential presence of small rocks and metal fragments in the product. Conagra Brands was made aware of this issue through calls from consumers.  Conagra has received two reports to date of injury (dental damage) associated with the recalled product. Consumers who have purchased this product are advised to dispose of it.

This is a reformed product (like a tater tot), so did rocks get into the equipment and damage the blades, thus a recall for both rocks and metal?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/conagra-brands-issues-voluntary-recall-certain-birds-eye-broccoli-totsr-due-potential-presence-small

Conagra Brands Issues Voluntary Recall of Certain Birds Eye Broccoli Tots® Due to Potential Presence of Small Rocks and Metal Fragments in Product
Summary
Company Announcement Date:  November 19, 2021
FDA Publish Date:  November 24, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Potential presence of small rocks and metal
Company Name:  Conagra Brands, Inc.
Brand Name:  Birds Eye
Product Description:  Frozen Broccoli Tots

Imported Cauliflower From China Recalled After State Laboratory Finds Listeria

Flagship Food Group of Eagle, Idaho is voluntarily recalling a limited number of cases of frozen cauliflower, TJ Farms Select brand, because it has the potential to be contaminated with Listeria monocytogenes.  The cauliflower was imported from China and the affected lot code and UPC are located on the back panel lower left corner of the bag. The impacted product was distributed in PA, TN, and WI. This voluntary recall is initiated due to a single sample of cauliflower which yielded a positive result for Listeria monocytogenes in a random sample test conducted by the Minnesota Department of Agriculture.

This issue would be covered as part of the company's FSVP for this supplier.  Was Listeria identified as a hazard, and what verification actions were being conducted to demonstrate safety with regard to Listeria?  A good guess is that Listeria would not be limited to this one lot.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/flagship-food-group-recalls-frozen-cauliflower-because-possible-health-risk
Flagship Food Group Recalls Frozen Cauliflower Because of Possible Health Risk
Summary
Company Announcement Date:  November 24, 2021
FDA Publish Date:  November 24, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Possible Listeria monocytogenes contamination
Company Name:  Flagship Food Group
Brand Name:  TJ Farms Select
Product Description:  Frozen Cauliflower

Soup in Glass Jars Recalled After Customer Finds Piece of Glass

Fischer & Wieser Specialty Foods is recalling 31.4-ounce jars of H-E-B Creamy Tomato Basil Soup due to the possible presence of glass in the product.  The recall was initiated after a customer notified the supplier that the product contained a glass piece. No injuries have been reported to date. All products related to this recall have been removed from H-E-B store shelves.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fischer-wieser-specialty-foods-issues-voluntary-recall-h-e-b-creamy-tomato-basil-soup
Fischer & Wieser Specialty Foods Issues Voluntary Recall of H-E-B Creamy Tomato Basil Soup
Summary
Company Announcement Date:  November 23, 2021
FDA Publish Date:  November 23, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Potential presence of glass
Company Name:  Fischer and Wieser Specialty Foods
Brand Name:  H-E-B
Product Description:  H-E-B Tomato Basil Soup

Shrimp Soup Stock Recalled for Containing Undeclared Fish

JFC International Inc. of Los Angeles, CA is voluntarily recalling a Wel-Pac Shrimp Dashi No Moto soup stock because it was found to contain undeclared fish (Bonito, Sardine, Tuna).   The recall was initiated after JFC was notified of an undeclared allergen by the manufacturer. JFC immediately responded to this issue and has already taken action to cease sales and distribution of the affected product. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jfc-international-inc-issues-allergy-alert-undeclared-fish-bonito-sardine-tuna-wel-pac-shrimp-soup
JFC International Inc. Issues Allergy Alert on Undeclared Fish (Bonito, Sardine, Tuna) in Wel Pac Shrimp Soup Stock
Summary
Company Announcement Date: November 22, 2021
FDA Publish Date: November 23, 2021
Product Type:  Food & Beverages Soup
Reason for Announcement:  Undeclared fish allergen (bonito, sardine, tuna)
Company Name:  JFC International, Inc.
Brand Name: Wel-Pac
Product Description:  Shrimp Powdered Soup Stock

FDA Warning Letters - Three Importers Cited for FSVP Violations

FDA issued Warning Letters to three importers on issues involving compliance to FSVP.  The FSVP regulation is in place to ensure that food entering into the US meets US food safety standards.

California Terra Garden Inc. of  Commerce CA, an importer of mushrooms, did not take compliance with the Produce Safety Rule into account when approving the supplier and did not have adequate assurance that the significant hazards were being controlled.as required by the Produce Safety Rule.  The supplier information was not translated into English

Bella Rosa Distribution Inc of Minneapolis, MN did not develop, maintain, and follow an FSVP for any of the foods you import, including the following three foods:

JD's Market Inc. of Lynnwood, WA 98036-6601 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, you did not develop, maintain, and follow an FSVP for any of the foods you import

Sichuan Chili BBQ Rub Spice Blend Recalled After Wrong Product Packaged in Jars Resulting in Undeclared Sesame

The Spice House is voluntarily recalling Sichuan Chili BBQ Rub because it may contain undeclared sesame.  The product is being recalled because the wrong spice blend may be in the bottle and therefore it could contain undeclared sesame. Less than 40 jars of the product are affected by this issue, but all Sichuan Chili BBQ Rub produced is being recalled.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/spice-house-issues-allergy-alert-undeclared-sesame-sichuan-chili-bbq-rub
The Spice House Issues Allergy Alert on Undeclared Sesame in Sichuan Chili BBQ Rub
Summary
Company Announcement Date:  November 22, 2021
FDA Publish Date:  November 22, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared sesame
Company Name:  The Spice House
Brand Name:  The Spice House
Product Description:  Sichuan Chili BBQ Rub