FDA Warning Letter Issued to Kansas Bakery for Significant GMP Issues

FDA issued a Warning Letter to a Kansas Bakery after an extended inspection in August of 2021.  The company had not issued a response to the observations that were noted on the  Inspection Form 483.

There are a number of issues cited under each of these items.
Item 1 - Lots of bugs including cockroaches and flies.
Item 2 - Really dirty equipment

Item 3 - Poor employee practices when working with RTE foods

Looking at the facility on Google Street View, it is hard to believe that FDA was able to find this shack-like building.

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bakery-project-inc-dba-delano-bakery-617718-01042022
Bakery Project Inc. dba Delano Bakery
MARCS-CMS 617718 — JANUARY 04, 2022

CT Ice Cream Company Expands Listeria Related Recall To Include all Products

The Royal Ice Cream Company, Inc. of Manchester, CT is expanding its recall of February 6 to include all products manufactured at the facility within the expiration date (as we guessed).   According to the release, "The recall was initiated by Royal Ice Cream after FDA sampling revealed the presence of Listeria monocytogenes on processing equipment. The company is holding future product and testing before releasing distribution of the products as FDA and the company continue their investigation as to what caused the problem."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/royal-ice-cream-company-inc-expands-recall-all-products-within-expiry-because-possible-health-risk
The Royal Ice Cream Company, Inc. Expands Recall All Products Within Expiry Because of Possible Health Risk
Summary
Company Announcement Date:  February 11, 2022
FDA Publish Date:  February 12, 2022
Product Type:  Food & Beverages
Ice Cream/Frozen Dairy  Foodborne Illness
Reason for Announcement:  Listeria monocytogenes
Company Name:  The Royal Ice Cream Company, Inc.
Brand Name:  Royal Ice Cream, Batch, Ronny Brook, and Others
Product Description:  Ice Cream Products

More Enoki Mushrooms Recalled After Sampling Finds Listeria Risk

Two companies are conducting recalls of enoki mushroom due to the potential for Listeria contamination.  

• CONCORD FARMS of Vernon, CA is recalling its 5.25oz (150g) enoki mushrooms, Lot #045633 grown in Korea, after sampling by California Dept of Health (CDPH)
• Jan Fruits Inc. of VERNON, CA is recalling all its cases of its 200g/7.05oz packages of ENOKI MUSHROOM (Product of Taiwan) because it has the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was discovered after a retail sample collected and analyzed by California Department of Public Health (CDPH) and revealed the presence of Listeria monocytogenes in 7.05 oz. package of Enoki mushroom.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/concord-farms-recalls-enoki-mushrooms-due-possible-health-risk-0
Concord Farms Recalls Enoki Mushrooms Due to Possible Health Risk
Summary
Company Announcement Date:  February 09, 2022
FDA Publish Date:  February 10, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Concord Farms
Brand Name: Concord Farms
Product Description:  Enoki Mushrooms 

Additional Companies Recall Dried Plums for Lead Levels in Violation of California's Prop 65

Additional companies issued recalls of dried plums for potential to be contaminated from lead.  In the notices, we can see that companies are issuing recalls after testing by the CA State Laboratory found samples were in violation concerning the Prop 65.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-gourmet-recalls-saladitos-dry-salted-plums-because-possible-health-risk
American Gourmet Recalls Saladitos Dry Salted Plums Because of Possible Health Risk
Summary
Company Announcement Date:  February 10, 2022
FDA Publish Date:  February 10, 2022
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Potential to be contaminated with lead
Company Name:  American Gourmet
Brand Name:  American Gourmet
Product Description:  Saladito (Dried Salted Plums)

Europe - Ongoing Salmonella Outbreak Associated with Eggs Affects Close to 300

The European Center of Disease Prevention and Control (ECDC) provided a report of an ongoing Salmonella outbreak of 272 cases and 2 deaths (Denmark (n=3), France (n=216), the Netherlands (n=12), Norway (n=7), Spain (n=22), and the UK (n=12)). The organism was linked to an earlier outbreak in 2019 which point to a Spanish farm, although the data suggests a wider distribution where "there may be multiple heterogeneous sources of S. Enteritidis ST11, and the outbreak strain could also be circulating at other farms, inside or outside Spain."

European Centre for Disease Prevention and Control
https://www.ecdc.europa.eu/en/publications-data/multi-country-outbreak-salmonella-enteritidis-sequence-type-st11-infections
Multi-country outbreak of Salmonella Enteritidis sequence type (ST)11 infections linked to eggs and egg products

Three Food Importers Issued Warning Letters for Not Having Required FSVP for Imported Food Products

FDA issued Warning Letters to three food importers for not having FSVP for the items they import.

• Molino Enterprises One, Inc., located at 392 E 197th Street, Bronx, NY did not develop, maintain, and follow an FSVP for imported whole wheat breadsticks.
• Ding Tea Balboa located at 5945 Balboa Ave., San Diego, CA 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.
• VHRK Food Inc., located at 810 Bonnie Lane, Elk Grove Village, IL.did not develop an FSVP for any of the foods imported, including the following  Dry dates powder, Brown Chori (peas), Black pepper, and Sun dried gooseberries

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/molino-enterprises-one-inc-619323-01072022
Molino Enterprises One, Inc.
MARCS-CMS 619323 — JANUARY 07, 2022

Chicago Kimchi Operation Receives a Deserved Warning Letter

FDA issued a Warning Letter to 5,000 Years Foods of Chicago IL, a company that produces kimchi.  Basically,  the company downloaded some record keeping logs from the internet to make it look like they had controls in place, but between the lack of real controls and a slew of GMP issues that made this far to much to provide in a short summary.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/5000-years-foods-inc-617797-01272022
5,000 Years Foods, Inc.

FDA Issues Warning Letter to Dairy Powder Packer with Serious Salmonella Contamination Issues in Facility

FDA issued a Warning Letter to OFP ingredients after an inspection of their tolling operation for dry milk powder processing located in Oconomowoc, Wisconsin.  The facility processes agglomerated milk powders that are sold for further blending into beverages or for further packaging, and are considered RTE because they are consumed without further processing to significantly minimize biological hazards.  
 

The biggest concern was that FDA found Salmonella on environmental samples which demonstrated a lack of control.  "FDA laboratory analysis confirmed 10 of 174 environmental swabs collected were positive for Salmonella Cubana. Of these positive findings, three positive swabs were collected from the (b)(4) room, a room that you consider a primary pathogen control area where products are exposed to the environment and include the following locations: a crack in the wall and floor junction adjacent to (b)(4); the floor and stair junction of the mezzanine level which employees climb to access ribbon blenders; and the floor drain cover adjacent to the mezzanine stairs. Additionally, three positive swabs were collected from the agglomeration room, including the equipment framework under Line (b)(4)."

Further, this Salmonella strain was determined to be a resident organism.  Again, FDA - "Whole genome sequencing (WGS) was conducted on the Salmonella isolates obtained from the 2021 FDA environmental samples, and the current WGS analysis determined that the 2021 isolates matched isolates from three other environmental samples including FDA sample 437365, FDA sample 892439, and FDA sample 940886, which were collected from this facility location in 2009, 2016, and 2017, respectively. The presence of the same strain of Salmonella over multiple years indicates there has been a resident pathogen in your facility since at least 2009."

The facility was trying to control the environment through prerequisite programs rather than establishing this as a Sanitation Preventive Control.  The company's own environmental testing program had found salmonella, but they never did sufficient corrective action to eliminate the organism.  In addition, GMP issues seemed to be spreading the organism (fork lifts with positive samples on the wheels).

History has shown that facilities with this level of contamination will be hard pressed to rid itself of this resident Salmonella.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ofp-ingredients-llc-617124-12072021

OFP Ingredients LLC

MARCS-CMS 617124 — DECEMBER 07, 2021

Iowa Creamery Issued Warning Letter for Not Knowing How to Label Food Products Properly

FDA issued a Warning Letter to Picket Fence Creamer of Woodward, Iowa after finding twelve flavors of ice cream and three flavors of cheese curds contained undeclared ingredients and sub-ingredients.  From the notice, the company failed to identify ingredients and also failed to detail the makeup of certain ingredients (listing the sub-ingredients).  Makes you wonder if they were controlling allergens from product to product.

While a small farm producer, they were distributing their food items to retail stores.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/picket-fence-creamery-llc-618726-01142022
Picket Fence Creamery LLC

MARCS-CMS 618726 — JANUARY 14, 2022