California Bakery Cited for Failure to Comply with Any Regulations

FDA issued a Warning Letter to a California Bakery.  To make the long notice short [I really don't want to type this one out], the firm operated as if they had no knowledge of regulations.  There was no food safety plan, and with that, no controls for allergens, environmental pathogens, etc.  The firm lacked GMPs including pest control, personal hygiene, proper cleaning, etc.  They also had issues with using unapproved color additives and improper labeling.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sheng-kee-california-inc-dba-sheng-kee-bakery-668255-04242024
Sheng Kee of California, Inc dba Sheng Kee Bakery
MARCS-CMS 668255 — APRIL 24, 2024

Canning Firm in China Cited by FDA for Failure to Meet LACF Regulations

FDA issued a Warning Letter to a low acid canned food (LACF) facility, located on Huarong County, Yueyang, Hunan, China. 

• Did not process a food in conformity with at least the scheduled process filed with FDA as required by 21 CFR 108.35 including: products produced in 2023 were processed at a different time and temperature than the scheduled process filed with the FDA
• The heat distribution study does not adequately support the scheduled process filed with the FDA.
• The firm’s retorts did not have an accurate temperature-recording device as required by 21 CFR 113.40(b)(2)
• The processing and production records for products failed to document the specific product variety, approximate number of containers per coding interval, initial product temperature, temperature-indicating device readings, and temperature recording device readings. Additionally, as these USA products are produced in a horizontal still water (b)(4) retort, the firm failed to document time steam on, time temperature up to processing temperature, time steam off, and venting time and temperature to which vented. The abovementioned data is also not documented or recorded on processing and production records for any of the LACF products the firm produces for the USA market.
• The firm did not use or document any form of heat-sensitive indicators or other effective means to ensure the baskets have been processed in the horizontal still water (b)(4) retorts used to process the USA low-acid canned food products.
• The firm’s only printed identification code for  USA hermetically sealed pouches consists of a 10-month best by date, which does not adequately identify the establishment where packed, the product in the container, year packed, day packed, or period during which packed
• The firm did not reference  (b)(4) thermometer to document the retort processing temperature. By the admission of your Equipment & Maintenance Manager, the firm relies on the (b)(4) digital temperature control probe display to document the processing temperatures on the horizontal still water (b)(4) retorts ((b)(4)) used to process LACF products for the USA market.
• The General Manager, Assistant Quality Control Manager, and the Equipment & Maintenance Manager, and none of the processing system or retort operators have ever attended training for thermally processing low-acid canned foods, such as a Better Process Control School, nor are they under the supervision of anyone who has completed such training.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hunan-gagazui-food-co-ltd-673799-02092024
Hunan Gagazui Food Co., Ltd.
MARCS-CMS 673799 — FEBRUARY 09, 2024

Warning Letter Issued to Spanish Seafood Processor for Inadequate HACCP Plan

The FDA issued a Warning Letter after conducting a Foreign Regulatory Assessment (FRRA) of a  seafood processing facility, located in Sevilla, Spain on October 2 through October 11, 2023. During that assessment, FDA found that the company had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.  This included that the firm’s HACCP plan for green olives stuffed with anchovy or tuna did not list the food safety hazard of scombrotoxin (histamine) formation, Staphylococcus aureus (S. aureus) growth and toxin formation, and allergens associated with the tuna and anchovies; and the food safety hazard of S. aureus growth and toxin formation associated with the olives cooked and fermented at your facility.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jolca-sa-677664-03212024
Jolca, S.A.
MARCS-CMS 677664 — MARCH 21, 2024

FDA Warning Letter to Foreign Supplier Highlights the Need for Supplier Preventive Controls

FDA issued a Warning Letter to a Chinese manufacture of RTE soy protein isolate.  FDA inspected the food manufacturing facility, located in Ye County, Pingdingshan, Henan, 467200, China from August 15 to 17, 2023. Soy protein isolate is used as a protein source in a number of food items including as an ingredient in smoothie mixes, pancake mixes, and breakfast ceral.

This is a great demonstration for the need of a tight Supplier Preventive Control as part of the Preventive Controls for Human Foods OR as part of a FSVP.  Note the issue with Certificates of Analysis (COAs).   A good reason to always verify COA with one's own testing.  This is especially important since this is considered a RTE ingredient.

Issues included:

• 'The hazard analysis covering the RTE Soy Protein Isolate did not identify the hazard of recontamination with environmental pathogens (e.g., Salmonella) as requiring a preventive control.'   
• 'Further, after employees completed and documented cleaning of the packing room, the investigator visually observed apparent soy protein powder residue on food-contact surfaces including the manual hand scoop, powder filling spout, and air removal probes.  The also visually observed soy protein powder residue on food-contact surfaces including the manual hand scoop, powder filling spout, and air removal probes.' 
• 'The production manager also informed the investigator that the only method of sanitization for the equipment in the packaging room is turning on the ceiling-mounted ultraviolet light for (b)(4) minutes before starting packaging. Of course, the company must ensure that the sanitization system is effective in reducing environmental pathogens on food-contact packaging surfaces to a safe level (including those far from the light source, those where the light might not reach, and those with organic residues.)'
• The firm did not take effective measures to exclude pests from the processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, including a live insect was observed crawling inside the facility’s post-heat treatment packaging room for the RTE soy protein products; three live crawling insects and two dead insects were observed on the floor of the spray dryer room, which is directly adjacent and connected to the post-heat treatment packaging room; and a gap was observed at the bottom of the packaging room entry doors.
• Failed to properly store equipment, remove litter and waste, and cut weeds and grass within the immediate vicinity of the plant thus constituting an attractant, breeding place, or harborage for pests, as required by 21 CFR 117.20(a)(1). Specifically, the exterior ground along the south side of the facility was overgrown with weeds and being used as a storage area for scrap metal and old equipment. This area is directly outside the soy packaging room.
• The firm provided the investigator with certificates of analysis (COAs) for outgoing shipments of Soy Protein Isolate to U.S. customers which included results for Salmonella and E. coli testing. However, the firm had no original testing data to support the results on the COA. According to the Laboratory Manager and Food Safety Plan Systems manager, the firm sends their U.S. customers COAs with data that is not supported by actual results but creates the COA with values to satisfy the customer specifications. The firm then performs testing after the batches are sent to the U.S.; however, the testing does not include Salmonella or E. coli.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pingdingshan-tianjing-plant-albumen-co-ltd-675567-04172024
Pingdingshan Tianjing Plant Albumen Co., Ltd.
MARCS-CMS 675567 — APRIL 17, 2024

CA Firm Recalls Yogurt Covered Pretzels After Yogurt Coating Supplier Finds Salmonella

Western Mixers Produce & Nuts, Inc. of Ontario, CA is recalling Yogurt Covered Pretzels, because the yogurt coating has the potential to be contaminated with Salmonella,  The recall was as the result of a routine sampling program by the source supplier of the yogurt coating, which revealed that the finished products contained the bacteria. The company has ceased the production and distribution of the product as FDA and the company continue their investigation as to what caused the problem.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/western-mixers-produce-nuts-inc-recalls-yogurt-covered-pretzels-because-possible-health-risk
Western Mixers Produce & Nuts, Inc. Recalls Yogurt Covered Pretzels Because of Possible Health Risk
Summary
Company Announcement Date:  May 10, 2024
FDA Publish Date:  May 10, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Salmonella
Company Name:  Western Mixers Produce and Nuts
Brand Name:  First Street, Gelson’s, bulk at Down Home Goods and Thorp Fruit
Product Description:   Yogurt covered pretzels

Washington State Firm Recalls Goat Milk Infant Formula Kit After Adverse Event in Infant

Healthwest Minerals, Inc. d/b/a Mt. Capra Products of Chehalis, Washington, is recalling 1,506 boxes of Goat Milk Formula Recipe Kit on the recommendation of the Food and Drug Administration (FDA) and advises consumers to immediately discontinue use of the product as infant formula. The FDA is concerned that the formula does not meet all FDA requirements for infant formula, does not provide sufficient nutrition when used as an infant formula, and the storage instructions may be insufficient for the product. Infants consuming the recalled product without additional iron supplementation can develop iron deficiency anemia and feeding intolerance.

FDA notified Mt. Capra of an adverse event report of anemia in one infant. FDA determined that while the caregivers were using the Goat Milk Formula Recipe Kit and recipe, the caregivers substituted some ingredients with a different brand of multivitamin, which created a product deficient in vitamin B12 as well as folate and ultimately resulted in the development of anemia.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/healthwest-minerals-inc-dba-mt-capra-products-recalls-goat-milk-formula-recipe-kit-and-warns
Healthwest Minerals Inc. DBA Mt Capra Products Recalls Goat Milk Formula Recipe Kit and Warns Consumers Against the Use of Product as Infant Formula
Summary
Company Announcement Date:  May 10, 2024
FDA Publish Date:  May 10, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Product does not provide sufficient nutrition when used as an infant formula
Company Name:  Healthwest Minerals, Inc. dba Mt. Capra Products
Brand Name: Mt. Capra
Product Description:  Goat Milk Formula Recipe Kit

Japan - Rat Parts Found in Bread

In Japan, a major food company issued a recall for over 100,000 packs of sliced white bread after rat parts were found in the product.  In a statement on Wednesday, Pasco Shikishima Corporation said it was investigating how parts of “a small animal” [a rat] found its way into two packets of sliced bread, adding that no one has fallen sick so far after consuming the product."  "They were found in a batch of white “chojuku” bread — or super fermented bread, known for its extra chewy texture — manufactured by a factory based in western Tokyo prefecture, according to the company."

Perhaps a name change is in order....ratachewy.

CNN

https://www.cnn.com/2024/05/09/food/japan-bread-rat-parts-recall-intl-hnk
Rat parts found in sliced white bread in Japan, sparking recall
By Chris Lau and Himari Semans, CNN
Updated 2:38 AM EDT, Thu May 9, 2024
Tokyo

Texas Nut Company Recalls All Products for Never Having Adhered to Allergen Regulations

Texas Pecan of Dallas TX is recalling 1 Lb and 8 oz products because it may contain an undeclared allergens - cashews, filberts, macadamias, pistachios, pecans, pine nuts, walnuts, soy, dairy (milk), sesame and wheat.

According to the company, "The problem came about with a routine check from the Texas Department of state and Health Services. When they inspected the packaging machine they decided that cross contamination was possible as our labels do states tree nut but each tree nut was not named individually. Our packaging machine is cleaned properly however our written documentation did not clearly state that."  They further state, "his company has been in business for over 40 years and no sickness or allergic reaction has ever been reported to us."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/texas-pecan-issues-allergy-alert-undeclared-tree-nuts-not-named-individually-soy-dairymilk-sesame
Texas Pecan Issues Allergy Alert on Undeclared Tree Nuts (Not Named Individually), Soy, Dairy(Milk), Sesame and Wheat Not Named in Product
Summary
Company Announcement Date:  May 08, 2024
FDA Publish Date:  May 08, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanut, tree nuts, soy, milk, sesame, and wheat allergens
Company Name:  Texas Pecan
Brand Name:  Texas Pecan Company
Product Description:  1 lb and 8 oz nuts, snack mixes, seeds, snack sticks

Iowa Retailer Recalls Cream Cheese Spread and Cookies and Cream Mix for Salmonella After Co-manufacturers Issue Notification

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling two varieties of its Hy-Vee Cream Cheese Spread  and bulk-packaged Cookies & Cream Mix out of an abundance of caution due to the potential for contamination with Salmonella.  These products are manufactured at different third-party facilities around the Midwest and are sold under HyVee’s private label and bulk packaging programs. The manufacturers of these products notified Hy-Vee of the potential issue.

No illnesses have been reported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/recall_supplier-recalls-impact-two-hy-vee-products-third-party-manufacturers-alert-retailer
Recall_Supplier Recalls Impact Two Hy-Vee Products Third-Party Manufacturers Alert Retailer of Potential for Contamination; No Illnesses Reported
Summary
Company Announcement Date:  May 06, 2024
FDA Publish Date:  May 06, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Salmonella
Company Name:  Hy-Vee Inc
Brand Name:  HyVee
Product Description:  Plain Whipped Cream Cheese, Plain Cream Cheese, and Cookies & Cream Mix