FDA warns food firms in China and California about unsanitary conditions, insects, and more

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

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Pingdingshan Tianjing Plant Albumen Co., Ltd.
Ye Xian Pingdingshan Shi Henan Sheng, China

A food firm in China is on notice from the U.S. Food and Drug Administration (FDA) for violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

In an April 17, 2024 warning letter, the FDA described an August 15-17, 2023, inspection of Pingdingshan Tianjing Plant Albumen Co. manufacturing facility in China.

FDA investigators found that the ready-to-eat (RTE) Soy Protein Isolate manufactured in their facility is adulterated because it was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health. 

After the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, listing deviations found at the facility.

Some of the significant violations are as follows:

Hazard Analysis and Risk-Based Preventive Controls

1. The firm did not appropriately evaluate a known or reasonably foreseeable hazard to determine whether it requires a preventive control. Specifically, their hazard analysis covering in their RTE Soy Protein Isolate did not identify the hazard of recontamination with environmental pathogens (e.g., Salmonella) as requiring a preventive control. Their hazard analysis included within their HACCP plan collected during the inspection indicates that sanitation is managed through a pre-requisite program which states that packing personnel operate according to standard operating procedures. However, their facility manufactures RTE Soy Protein Isolate which is exposed to the environment after their “(redacted by FDA)” step prior to packaging. The firm’s employees hand-pack the Soy Protein Isolate using a scoop and the packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in their circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation controls). Thus, their hazard analysis should have concluded that environmental pathogens such as Salmonella are a hazard requiring a preventive control (i.e., sanitation controls). Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens.

Furthermore, 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.

Additionally, the firm’s production manager informed the investigator that they use a vacuum for cleaning their post-lethal treatment direct food-contact surfaces in their packaging room. However, after employees completed and documented cleaning, the investigator visually observed soy protein powder residue on food-contact surfaces including the manual hand scoop, powder filling spout, and air removal probes. The firm’s 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 (redacted by the FDA) minutes before starting packaging. They should ensure that their 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.)

2. The firm did not take effective measures to exclude pests from their processing, packing, and holding areas and to protect against the contamination of food on the premises by pests. Specifically:

i. A live insect was observed crawling inside the facility’s post-heat treatment packaging room for their RTE soy protein products.
ii. Three live crawling insects and two dead insects were observed on the floor of their spray dryer room, which is directly adjacent and connected to their post-heat treatment packaging room.
iii. A gap was observed at the bottom of the packaging room entry doors.

3. The firm failed to properly store equipment, remove litter and waste, and cut weeds and grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests. 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 their soy packaging room.

Additional Comments:

During the inspection, 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 their 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.

The full warning letter can be viewed here.

Shang Kee of California Inc. dba Sheng Kee Bakery
Brisbane, CA

A food firm in California is on notice from the U.S. Food and Drug Administration (FDA) for violations of the Current Good Manufacturing Practice, as well as Color Additive Adulteration, and Misbranded Foods.

In an April 24, 2024 warning letter, the FDA described an Aug. 14-31, 2023, inspection of Sheng Kee Bakery’s manufacturing and distributing facility in Brisband, CA.

FDA investigators found significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. After the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, listing deviations found at the facility.

Some of the significant violations are as follows:

Hazard Analysis and Risk-Based Preventive Controls:

1. The firm did not prepare, or have prepared, and implement a food safety plan. The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs). The firm’s food safety plan must also include the following:

1) The written hazard analysis;
2) The written preventive controls;
3) The written supply-chain program;
4) The written recall plan;
5) The written procedures for monitoring the implementation of the preventive controls;
6) The written corrective action procedures; and
7) The written verification procedures.

However, they did not have a food safety plan with any of the required elements. For example, they did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control. Also, they did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated or misbranded. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan. Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system. They must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system. Specifically:

a. The firm did not identify and evaluate allergens as a known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. Their facility manufactures Ready-to-eat (RTE) and non-RTE bakery products that contain allergens such as egg, soy, wheat, milk, sesame, peanuts and tree nuts. Allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in their circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label..

The firm did not perform and document the review of labels for proper declaration of allergens. For example, on Aug. 15, 2023, FDA observed their employees apply an egg wash to their two Cantonese-style mooncake lines, producing Lotus Mooncake and Red Bean Mooncake. They did not identify egg as an ingredient in their product labels for Assorted Mini Moon Cake (9 PCS), Assorted Mini Moon Cake (12 PCS), Assorted Large Moon Cake (4 PCS), and Assorted Large Moon Cake (4 PCS/TIN PACK). As a result, the firm recalled these products on Sept. 1, 2023.

b. For their RTE bakery products, they did not identify environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. Their facility manufactures RTE bakery products which are exposed to the environment after baking and handled by employees prior to packaging. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in their circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling. In addition, environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control. In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventative control. The firm is not performing environmental monitoring to evaluate the effectiveness of their sanitation practices regarding employee practices and cleanliness of food contact surfaces.

c. The firm did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Their facility manufactures bakery products from wheat, soy and tree nuts. These ingredients have been associated with mycotoxins. A knowledgeable person manufacturing/ processing food in their circumstances would identify mycotoxins as a hazard requiring a preventive control in these ingredients. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients. The supply-chain program must include using approved suppliers and conducting supplier verification activities. They do not have this program in place.

Current Good Manufacturing Practice:

1. The firm did not take effective measures to exclude pests from the food plant to protect against the contamination of food on the premises by pests.

a. On Aug. 15, 2023, the FDA investigator observed apparent flying insects in mixing bowls, which employees planned to use for a cold dessert mix.
b. On Aug. 14, 2023, the FDA investigator observed numerous apparent flying insects in the ambient warehouse where the firm stores ingredients, food products, processing equipment, and various other items, and the large loading door was left open directly to the outdoors during operational hours. In addition, flying insects were observed in each of the production rooms where food was being processed.
c. On Aug. 14, 2023, the FDA investigator observed apparent insects crawling on the floor near a pile of flour underneath their flour silo and observed apparent live spiders in their ambient storage warehouse, Recipe/Prep Room and in the Electrical Room where they store ingredients.

2. The firm failed to take reasonable measures or precautions related to personnel practices. Specifically,

a. On Aug. 14, 2023, FDA observed that their employees were storing personal belongings, including personal clothing, cell phones and water bottles, in the production areas where food is exposed. FDA also observed a partially eaten bag of crackers in the washroom on top of the (redacted by FDA) where equipment was being cleaned.
b. On Aug. 17, 2023, one employee was observed applying egg wash and sprinkling sesame on Egg Bread, then checking his cell phone, and returning to applying egg wash and sprinkling sesame without washing his hands.

3. The firm failed to clean non-food contact surfaces of equipment used in the operation of a food plant in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials. Specifically:

a. On Aug. 17, 2023, the FDA investigator observed that cutting and application utensils were stored against the wall, hung on a discolored and dirty metal pipe.
b. On Aug. 14, 2023, the FDA investigator observed the steel frame shelves used to store clean bowls, utensils, containers, ingredients, and equipment in their production rooms and storage areas were unclean and had accumulated debris or residue on their surfaces. The investigator also observed employees grabbing mixing bowls and using them without additional cleaning.
c. On Aug. 15, 2023, the FDA investigator observed the interior of their (redacted by FDA), specifically the internal machine components under the lid, had accumulated a large amount of blackened residue and debris, and there was also an apparent dead spider.

4. The firm did not store and transport food under conditions that protect against allergen cross-contact, contamination of food, and deterioration of food. Specifically,

a. On Aug. 14, 2023, an FDA inspector observed a bag of raw onions stored on the floor of their cooler room. They also observed various food containers being stored on the floor in the storage and processing areas, including pails of chocolate powder and pails of filling/paste for bread and cakes.
b. On Aug. 17, 2023, the FDA investigator observed blocks of chocolates, to be used as chocolate shavings on top of RTE cake, stored against the wall on a table and in direct contact with a dirty electrical cable.

5. The firm’s plant is not constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept in good repair. Specifically, during the inspection of their facility, the FDA investigator observed apparent black residue on walls, ceilings and floor in the production room, coolers, freezers, blast freezer and ambient warehouse. The black material was also present in washroom and cake room where sanitation is performed, including on sinks and near sanitizer dispensers.

Color Additive Adulteration

The firm’s Egg Bread and Green Tea & Milky Pudding products are adulterated because the products bear or contain a color additive which is unsafe. Certain color additives have been deemed to be unsafe unless its use is in conformity with the color additive listing regulation. Specifically, the listing regulation for FD&C Yellow No. 5 requires that certified color additive be listed by that name in the ingredient list on the labels of foods for human use.

• The firm’s Egg Bread product is manufactured with (redacted by FDA) which contains FD&C Yellow No. 5; however, the label for this product fails to declare FD&C Yellow No. 5 in the ingredient statement.
• The firm’s Green Tea & Milky Pudding product is made using a Green Tea Flavored Powder which is labeled to contain Tartrazine (which may be certified as FD&C Yellow 5); however, the label for this product fails to declare FD&C Yellow No. 5 in the ingredient statement.

Misbranded Foods

1. The firm’s Assorted Mini Moon Cake (9 PCS), Assorted Mini Moon Cake (12 PCS), Assorted Large Moon Cake (4 PCS), and Assorted Tea Flavor Mini Moon Cake products are misbranded, in that the finished product labels fail to accurately declare major food allergens. Specifically, their Assorted Mini Moon Cake (9 PCS), Assorted Mini Moon Cake (12 PCS), Assorted Large Moon Cake (4 PCS), and Assorted Tea Flavor Mini Moon Cake do not declare the allergen of eggs from the egg wash used on all moon cakes.

“Major food allergens” are defined as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:

• The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, or
• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen.)

2. The firm’s Egg Bread and Green Tea & Milky Pudding products are misbranded because the products contain artificial coloring and fail to bear labeling stating that fact. Specifically:

• Their Egg Bread product is manufactured with (redacted by FDA) which contains FD&C Yellow No. 5 and FD&C Yellow No. 6 as ingredients; however, the product does not bear a label identifying the presence of these color additives using their listed names or appropriate abbreviations.
• The firm’s Green Tea & Milky Pudding product is manufactured using Green tea flavored powder ingredient. This ingredient declares “Tartrazine (E102) and Brilliant blue FCF (E133)” on its product label; however, the “Green Tea & Milky Pudding” product does not declare these color additives.
• The Egg Bread ingredient list declares calcium propionate; however, the preservative function is not declared in accordance with regulation.

3. The firm’s Assorted Mini Moon Cake (9 PCS), Assorted Tea Flavor Mini Moon Cake (12 PCS), and Assorted Large Moon Cake (4 PCS) products are misbranded because:

• The product labels contain information in a foreign language, but do not repeat all the required information in all languages. The net quantity of contents and Nutrition Facts (such as “Includes Added Sugars”) must be on the labels in all languages used on the labels. Further, for the Assorted Large Moon Cake (4 PCS), the ingredient list, Nutrition Facts label, firm addresses, and the net quantity of contents are not provided in the foreign language.
• The statement of identity on the Assorted Mini Moon Cake (9 PCS) and the Assorted Large Moon Cake (4 PCS) is not provided in English on the Principal Display Panel (PDP).
• The Mini Moon Cake (9 PCS), Assorted Large Moon Cake (4 PCS) and Assorted Tea Flavor Mini Moon Cake (12 PCS) labels do not declare the net quantity of contents in English on the PDP.
• The allergen “Contains” statements on the sticker labels are not placed immediately following or adjacent to the ingredient lists on the Assorted Large Moon Cake (4 PCS) and Assorted Tea Flavor Mini Moon Cake (12 PCS).

4. The firm’s Egg Bread is misbranded because its labeling is false or misleading. Specifically, the major food allergen, sesame, is declared in the ingredient list and the label includes a Contains statement but sesame is not declared in the Contains statement. FDA noted that if a “Contains” statement is used on a food label, the statement is to include the names of the food sources of all major food allergens used as ingredients in the packaged food. More information on Food Allergen Labeling Requirements and the “Contains” statement can be found in the publication “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry.”

5. The firm’s Assorted Tea Flavor Mini Moon Cake (12 PCS), the Assorted Mini Moon Cake (9 PCS), the Assorted Large Moon Cake (4 PCS), and the Egg Bread products are misbranded in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. 

The full warning letter can be viewed here.

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