Eyedrops Recalled Due to Contamination Leading to Severe Eye Infections, 483 Report Details QC Horrors At Foreign Manufacturer

Global Pharma Healthcare recalled all lots of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, due to possible contamination.  This product was identified by CDC as the source of "Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection."

The 483 Report (obtained from www.marlerblog.com) details an extremely bad operation.  

(https://www.marlerblog.com/files/2023/04/Global-Pharma-Healthcare-Ltd.-Tamilnadu-India-3.2.23-483.pdf)

This is an imported product.  We often wonder why some items are less expensive than branded products that are produced in the US.  Products produced in the US have to meet established sanitary standards.   

Observations from the report include:

Obs 1A.  Lack of validation support for demonstrating the equipment can be reliably sterilized.  And with that, the procedures were not followed for the required sterility filters.

Obs 1B. Improper filter testing

Obs 1C. Did not perform container closure integrity test adequately.

Obs 1D. Formulation not followed, specifically with inadequate preservatives.

Obs 1E Aseptic process lacked sterility assurance

Obs 1F. Airflow patterns insufficient (to demonstrate air control in aseptic environment)

Obs 1G Floors, walls, and ceilings were not appropriate for aseptic processing - cracks, holes, etc

Obs 1H Employees not qualified, did not follow appropriate procedures for aseptic environment.

Obs 2 - Test methods not established for accuracy, sensitivity, and reproducibility.
Obs 3 - Equipment does not have appropriate deisgn for how it is being used.

Obs 4 - Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic products.  Including (C) surfaces that contact the container closures is not cleaned.

Obs 5 - Failed to conduct test to verify identity of each component of the eye products.

Obs 6 - Failed to establish written procedures for cleaning and maintaining the equipment.

Obs 7 - Defient environmental monitoring.

Obs 8 - Laboratory controls  do not have specifications for conformance - what is acceptable.

Obs 9 - REcord reviews not completed and approved by QC 

Obs 10 - Stability samples not stored according to written procedures

Obs 11 - QC does not have responsibility and authority to approve, reject.

Yikes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntary-nationwide-recall-artificial-tears-lubricant-eye-drops-due
Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination
Summary
Company Announcement Date:  February 02, 2023
FDA Publish Date:  February 02, 2023
Product Type:  Drugs
Reason for Announcement:  Potential microbial contamination
Company Name:  Global Pharma Healthcare
Brand Name:  EzriCare & Delsam Pharma
Product Description:  Artificial Tears Lubricant Eye Drops

CDC - Salmonella Outbreak Linked to Flour - Investigation Notice 3-30-23

CDC and State partners are investigating a Salmonella outbreak that has been linked to raw flour. As of March 30, 2023, 12 people infected with the outbreak strain of Salmonella have been reported from 11 states (see map). Illnesses started on dates ranging from December 6, 2022, to February 13, 2023 (see timeline).

While an exact source is yet to be identified, it is important to follow proper practices when handling raw flour.

• Do not eat raw dough or batter.
• Clean surfaces and utensils that have residual raw flour with warm water or soap.
• Wash hands after handling raw flour, dough, or batter.
• Handle raw flour in a way that prevents it from cross contaminating surfaces that will not be cleaned immediately.
• Store raw flour properly, preventing it from getting over other surfaces or food.

Salmonella Outbreak Linked to Flour

https://www.cdc.gov/salmonella/infantis-03-23/index.html
Fast Facts
Illnesses: 12
Hospitalizations: 3
Deaths: 0
States: 11
Recall: No
Investigation status: Active

FDA Issues Warning Letter to CA Seafood Processor for Salmonella Contamination

FDA issued a Warning Letter to a CA seafood processing operation after an inspection was initiated as part of a multistate foodborne outbreak investigation of Salmonella Litchfield (S. Litchfield) infections linked to seafood, including fresh, raw salmon, supplied by the facility.  "According to the Centers for Disease Control and Prevention (CDC), 39 people from 4 states were infected with the outbreak strain of S. Litchfield. "

"FDA laboratory analyses found the presence of the outbreak strain of S. Litchfield and two additional Salmonella strains, Salmonella Mbandaka (S. Mbandaka) and Salmonella Oranienburg (S. Oranienburg), which are human pathogens, in [the] facility. On October 20, 2022, [the] firm recalled various types of fresh fish processed at [the] facility and distributed between June 14, 2022 and October 17, 2022, because they had the potential of being contaminated with Salmonella. FDA and CDC have determined, based upon the epidemiologic, traceback evidence, and whole genome sequencing (WGS) matches between clinical and FDA environmental samples, that fresh salmon processed at [the]  facility was the likely source of this multistate S. Litchfield outbreak"

Salmonella was found throughout the facility, which indicates poor sanitation among other poor practices.  Even though this is raw fish, Salmonella should not be present.

"Salmonella species are not endemic to seafood; therefore, FDA expects zero or non-detectable levels of Salmonella in seafood regardless of whether it is intended to be cooked before consumption or it is ready-to-eat (RTE). Salmonella in seafood is the result of human or animal fecal contamination of the harvest waters and/or fecal contamination during post-harvest handling and processing. The contamination can also be exacerbated by temperature abuse. Raw RTE seafood must have appropriate controls from harvest to consumption."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mariscos-bahia-inc-646401-02072023
WARNING LETTER

Mariscos Bahia, Inc.
MARCS-CMS 646401 — FEBRUARY 07, 2023

FDA Issues Warning Letter to Salad Dressing Bottler After Recall for Mislabeling

FDA issues a Warning Letter to Vanlaw Food Products after their Whole Foods 365 Organic Creamy Caesar Dressing sold in 10 fl. oz. clear glass bottles was mislabeled with the finished product back label having Classic Ranch Dressing and Dip and thus not declaring major food allergens, wheat and soy.
The company had similar recalls.  

• One being on September 19, 2022, where the expanded this recall after being notified by the customer of another lot of 365 Organic Creamy Caesar mislabeled with 365 Organic Classic Ranch Dressing and Dip back panel ingredient labels that do not declare wheat and soy. 
• On April 4, 2022, 365 Organic Creamy Caesar Dressing was recalled because of an incorrect back panel for Whole Foods Market Organic Blue Cheese applied to the product, which did not declare the allergens of wheat and soy

This is a pretty easy problem to fix if utilizing a properly designed Allergen Preventive Control for label application.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vanlaw-food-products-inc-641010-01052023

Vanlaw Food Products, Inc
MARCS-CMS 641010 — JANUARY 05, 2023
Recipient:
Mr. Pablo Gallo Llorente
President
Vanlaw Food Products, Inc
1851 North Delilah St.
Corona, CA 93879
United States

CR - 10 Risky Recalled Foods

Consumer Reports lists the 10 Foods Linked to Serious Recalls and Outbreaks and provides an explanation why each ended up there. They also provide some practical handling procedures

1. Leafy Greens
2. Cheeses and Deli Meat
3. Ground Meat 
4. Onions
5. Turkey
6. Chicken
7. Papayas
8. Peaches
9. Cantaloupe
10. Flour

While we can argue about what should be in the Top Ten, the information provided in this report is okay. 

The danger of any list like this is that people will avoid products because it is on 'the list'.   Onions for example...one should not avoid using onions, but follow practical handling procedures.  On the avoidance of pre-cut fruit...certainly if you are extremely risk averse, you would want to avoid pre-but fruit, otherwise, the overall risk is small when purchasing from a reputable producer.

A much better write-up than done in the past by this organization.

10 Risky Recalled Foods You Should Know About - Consumer Reports

Chocolate Bars From Costco Recalled Due to Undeclared Tree Nuts - Cashews

Wellness Natural USA Inc. of Wilmington, DE is voluntarily recalling a single lot of its SimplyProtein® Peanut Butter Chocolate Crispy Bar in the United States, which is sold in a 15-count variety pack that contains two other flavors, because it may contain an undeclared trace of tree nuts (cashews).   The recalled products were distributed in the United States in limited Costco stores in Arkansas, California, Washington DC, Kansas, Maryland, Oklahoma, Pennsylvania, Texas and Virginia.  The recall was voluntarily initiated due to a consumer complaint, which is the only reported reaction to date, and a determination that the lot may have the potential to contain trace levels of undeclared cashew. The cause of the contamination is being investigated.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wellness-natural-usa-inc-issues-allergy-alert-undeclared-cashews-simplyproteinr-peanut-butter
Wellness Natural USA Inc. Issues Allergy Alert on Undeclared Cashews in SimplyProtein® Peanut Butter Chocolate Crispy Bars
Summary
Company Announcement Date:  March 31, 2023
FDA Publish Date:  April 03, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared tree nuts (cashew)
Company Name:  Wellness Natural USA Inc.
Brand Name:  SimplyProtein
Product Description:  Peanut Butter Chocolate Crispy Bar

FL Company Recalls Smoked Salmon After State Testing Finds Listeria

Seven Seas International USA, LLC of St. Petersburg, Florida is voluntarily recalling 295 cases of Biltmore Smoked Sockeye Salmon with production lot R4058 because Listeria monocytogenes may be present in some product. The issue was discovered through routine regulatory testing conducted by the Florida Department of Agriculture and Consumer Services.  This product was distributed through Publix Supermarket.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/seven-seas-international-usa-llc-voluntarily-recalling-biltmore-smoked-sockeye-salmon-because
Seven Seas International USA, LLC is Voluntarily Recalling Biltmore Smoked Sockeye Salmon Because of Possible Health Risk
Summary
Company Announcement Date:  March 14, 2023
FDA Publish Date:  March 31, 2023
Product Type:  Food & Beverages  Fish
Reason for Announcement:  Potential Foodborne Illness/Listeria
Company Name:  Seven Seas International USA, LLC.
Brand Name:  Biltmore
Product Description:  Biltmore Smoked Wild Sockeye Salmon
Company Announcement  Date: March 14, 2023

Illinois Food Company Recalls Hamburger Skillet Meal After Mispacking Results in Undeclared Milk

Gilster Mary Lee, an  Illinois food company, is recalling one lot of HyVee Hamburger Chili Macaroni Skillet Meal, UPC 75450-08552 at the consumer level because it may contain undeclared milk.  Missouri, Kansas, Nebraska, South Dakota, Minnesota and Wisconsin. Gilster-Mary Lee Corp. became aware of the mispackaging after receiving an email from a customer. No illnesses have been reported to date in connection with this product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gilster-mary-lee-corp-issues-recall-undeclared-milk-allergen-hyvee-hamburger-chili-macaroni-skillet
Gilster-Mary Lee Corp. Issues a Recall for Undeclared Milk Allergen in HyVee Hamburger Chili Macaroni Skillet Meal
Summary
Company Announcement Date:  March 28, 2023
FDA Publish Date:  March 29, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Milk Allergen
Company Name:  Gilster-Mary Lee Corp.
Brand Name:  HyVee
Product Description:  Hamburger Chili Macaroni Skillet Meal

CA Distributor Recalls Sauces Due to Undeclared Soy

A California food distributor is recalling imported Worcester Sauce and Chuno Sauce due to undeclared soy on the label. The recall was initiated after it was discovered that product containing Soy was distributed in packaging that did not reveal the presence of Soy allergen

It seems that the Fermented Seasoning would be the source of the soy.





https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/north-american-food-distributing-company-inc-issues-allergy-alert-undeclared-soy-169-fl-oz-kagome
North American Food Distributing Company, Inc. Issues Allergy Alert on Undeclared Soy in 16.9 Fl Oz of Kagome Worcester Sauce and 16.9 Fl Oz of Kagome Chuno Sauce
Summary
Company Announcement Date:  March 28, 2023
FDA Publish Date:  March 29, 2023
Product Type: Food & Beverages  Gravy/Sauces
Reason for Announcement:  Undeclared Soy
Company Name:  North American Food Distributing Company, Inc.
Brand Name:  Kagome
Product Description:  Worcester Sauce; Chuno Sauce