Thursday, June 9, 2022

Monkeypox in the US - CDC Reports

CDC issued an Outbreak Report on Monkeypox in the US.  To this point in time, there have been 17 cases in 9 states.

The virus belongs to the family Poxviridae which are generally enveloped (externally although the intracellular mature virion form of the virus, which contains different envelope, is also infectious.) " The virion is exceptionally large, its size is around 200 nm in diameter and 300 nm in length and carries its genome in a single, linear, double-stranded segment of DNA"
  • In humans, the symptoms of monkeypox are similar to but milder than the symptoms of smallpox. Monkeypox begins with fever, headache, muscle aches, and exhaustion. The main difference between symptoms of smallpox and monkeypox is that monkeypox causes lymph nodes to swell (lymphadenopathy) while smallpox does not.
  • The incubation period (time from infection to symptoms) for monkeypox is usually 7−14 days but can range from 5−21 days.
  • Within 1 to 3 days (sometimes longer) after the appearance of fever, the patient develops a rash, often beginning on the face then spreading to other parts of the body.
  • Lesions progress through the following stages before falling off:
  • The illness typically lasts for 2−4 weeks
  • Human-to-human transmission occurs by direct contact with infected body fluids or lesions, via infectious fomites, or through respiratory secretions, that typically require prolonged interaction
  • A person is considered infectious from the onset of illness until all lesions have crusted over, those crusts have separated, and a fresh layer of healthy skin has formed under the crust
  • Prevention - Avoid contact with animals or humans that could harbor the virus (including animals that are sick or that have been found dead in areas where monkeypox occurs).
    • Avoid contact with any materials, such as bedding, that has been in contact with a sick animal.
    • Isolate infected patients from others who could be at risk for infection.
    • Practice good hand hygiene after contact with infected animals or humans. For example, washing your hands with soap and water or using an alcohol-based hand sanitizer.
    • Use personal protective equipment (PPE) when caring for patients.

FDA Issues Warning Letter to Juice Processor for HACCP Related Items

FDA issued a Warning Letter to a juice processor for issues associated with their HACCP plan.  One was the failure to take appropriate corrective action to a process deviation, and the other was inadequate validation of their process.

1)  The firm failed to take corrective actions when a deviation from a critical limit occurred during the manufacture of cold pressed citrus juice - 
"Review of your (b)(4) recording charts that monitor the (b)(4) critical limit of your citrus fruit (b)(4) treatment that uses (b)(4) to achieve a minimum 5-log reduction in the pertinent microorganism, revealed deviations from the critical limits identified in your Juice HACCP plan for cold pressed citrus juice with no corrective actions on November 11, 12, 15, and 16, 2021."

2) The firm did not validate that the HACCP plan is adequate to control food hazards when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way, as required by 21 CFR 120.11(b). 
"Specifically, you had an outside laboratory perform a process validation study, dated March 21, 2021, to determine whether the (b)(4) is an effective (b)(4) treatment critical control point (CCP) to achieve a minimum 5-log reduction for the control of (b)(4). The validation concluded that (b)(4) provides a minimum 5-log reduction in lemons, mandarins, limes, and oranges; a (b)(4) is required for grapefruit. The validation further stated that verification of the (b)(4) is an important part of this CCP. Your firm started producing (b)(4) treated citrus juice in April 2021 without adequate verification of the (b)(4) treatment as performed at your facility."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/russ-davis-wholesale-inc-628195-04282022
WARNING LETTER

Russ Davis Wholesale Inc
MARCS-CMS 628195 — APRIL 28, 2022

FDA Issues Warning Letters to Two Foreign Seafood Processors

FDA issued Warning Letters to two seafood processors, both located in China.  
One processor, Hainan Golden Spring Foods Co. Ltd., failed to do the appropriate level of drug testing on tilapia grown in aquaculture systems (I personally avoid eating tilapia because of these types of issues.)
The other firm, Zhoushan Haichang Co. Ltd, did not have a HACCP plan in place for swimming crab.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hainan-golden-spring-foods-co-ltd-629972-05042022
WARNING LETTER

Hainan Golden Spring Foods Co. Ltd.
MARCS-CMS 629972 — MAY 04, 2022

Additional Companies Issue Recalls After Using Recalled JIF Peanut Butter

These companies issued recalls for thier products where JIF peanut butter was used.  These come more than two weeks after the JIF peanut butter was initially recalled.

Taharka Brothers Ice Cream of Baltimore, Maryland is recalling its Peanut Butter Cup ice cream, because it has the potential to be contaminated with Salmonella. Affected Peanut Butter Cup ice cream was distributed between 03/01/2022 and 05/28/2022 to the Maryland and DC area through grocery stores, scoop shops, restaurants, and direct to consumer delivery. JIF brand peanut butter was used in the production of Peanut Butter Cup ice cream until 05/28/2022 and distributed to multiple retailers.

F&S Produce Co of Vineland, NJ is recalling a limited quantity of Protein Power Snack, because it contains a cup of 0.75oz JIF peanut butter which has the potential of being contaminated with Salmonella.

Prairie City Bakery of Vernon Hills, IL is voluntarily recalling select lots of Prairie City Bakery® Peanut Butter Chocolate Chip Ooey Gooey Butter Cake. The product contains Jif® peanut butter that was voluntarily recalled by the J.M. Smucker company on May 20, 2022, due to the potential for Salmonella contamination.

Illinois Company Recalls Sprinkles Due to Undeclared Milk

Wilton Industries, Inc. of Naperville, Illinois is initiating a voluntary national recall of select lots of Rainbow Chip Crunch Sprinkles And Rainbow Sprinkles Mix due to undeclared milk.  Although the product label does indicate that it may contain milk, this recall is being conducted because some samples of the product were found to contain milk.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wilton-brands-issues-allergy-alert-possible-presence-undeclared-milk-two-sprinkle-products
Wilton Brands Issues Allergy Alert on Possible Presence of Undeclared Milk in Two Sprinkle Products
Summary
Company Announcement Date:  June 02, 2022
FDA Publish Date:  June 06, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Milk
Company Name:  Wilton Industries, Inc.
Brand Name:  Wilton
Product Description:  Rainbow Chip Crunch Sprinkles and Rainbow Sprinkles Mix

CA Company Recalls Strawberry Tea Products After Produced with Strawberries Linked to Hepatitis A Outbreak

Urban Remedy, a California based producer of  fresh organic, ready-to-eat meals, juices and snacks, is voluntarily recalling Urban Remedy Organic Revitalizing Tea Tonic Strawberry Hibiscus Rose (LOT 1232 BEST BY 7/17/2022) because it has the potential to be contaminated with Hepatitis A. Urban Remedy contracts Youngstown Grape Distributors Inc. to co-manufacture this product. The product may contain fresh organic strawberries linked to the FDA outbreak investigation of FreshKampo organic strawberries.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/urban-remedy-recalls-urban-remedy-organic-revitalizing-tea-tonic-strawberry-hibiscus-rose-due
Urban Remedy Recalls Urban Remedy Organic Revitalizing Tea Tonic - Strawberry Hibiscus Rose Due to Possible Hepatitis A Contamination
Summary
Company Announcement Date:  June 03, 2022
FDA Publish Date:  June 05, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Hepatitis A.
Company Name:  Urban Remedy
Brand Name:  Urban Remedy
Product Description:  Organic Revitalizing Tea Tonic Strawberry Hibiscus Rose

Alabama Seafood Processor Recalls Crabmeat After FDA Finds Listeria in Cooking Operations

Irvington Seafood of Irvington, AL, is recalling its 1 lb. packages of "Crabmeat: Jumbo, Lump, Finger, and Claw meat" because they have the potential to be contaminated with Listeria monocytogenes
No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted on 05/27/22 after FDA tested on 05/09/22. FDA revealed the presence of Listeria monocytogenes on cooking equipment and cooking room. No crabmeat has been tested but product may have potentially been contaminated with Listeria monocytogenes due to cross contamination.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/irvington-seafood-recalls-crabmeat-jumbo-lump-finger-and-claw-meat-because-possible-health-risk
Irvington Seafood Recalls “Crabmeat: Jumbo, Lump, Finger, and Claw Meat” Because of Possible Health Risk
Summary
Company Announcement Date:  June 02, 2022
FDA Publish Date:  June 03, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Irvington Seafood Inc.
Brand Name:  Irvington Seafood
Product Description:  Crabmeat: Jumbo, Lump, Finger, and Claw meat

NJ Bakery Recalls Carrot Cake Squares Due to Undeclared Walnuts

Leonard Novelty Bakery of Moonachie NJ  announced today a recall involving Carrot Cake Squares sold in the store's Bakery departments due to undeclared walnuts

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/leonard-novelty-bakery-announced-recall-involving-carrot-cake-squares-due-undeclared-walnuts
Leonard Novelty Bakery Announced a Recall Involving Carrot Cake Squares Due to Undeclared Walnuts
Summary
Company Announcement Date:  May 17, 2022
FDA Publish Date:  June 02, 2022
Product Type:  Food & Beverages
 Reason for Announcement:  Undeclared walnuts
Company Name:  Leonard Novelty Bakery
Brand Name:  Leonard Novelty Bakery
Product Description:  Carrot cake squares

Missouri Cheese Manufacturer Recalls Cheese Due to Listeria

Paris Brothers, Inc., of Kansas City, Missouri is recalling several specific cheese products listed below because they have the potential to be contaminated with Listeria monocytogenes.  This recall is the result of routine sampling by the FDA, which revealed the presence of Listeria monocytogenes.
No illnesses have been reported to date.

The cheeses were produced on May 4, 5, and 6, 2022 are the only products in the recall.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/paris-brothers-inc-voluntary-limited-recall
Paris Brothers Inc. Voluntary Limited Recall
Summary
Company Announcement Date:  June 01, 2022
FDA Publish Date:  June 01, 2022
Product Type:  Food & Beverages  Cheese/Cheese Product
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
 Company Name:  Paris Brothers, Inc.
Brand Name:  Paris Brothers, Cottonwood River, D’amir, more
Product Description:  Cheese products