A bakery in Washington, a donut manufacturer in Iowa, and a fruit and vegetable warehouse in New York are all on notice from the Food and Drug Administration for violations of U.S. food safety laws.

The FDA sent warning letters to the companies earlier this month and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.

Starlight Desserts Inc.
In a March 21 warning letter to company president Emily A. Brune, the FDA described violations observed during an inspection Feb. 7-13, at the firm’s bakery in Seattle. According to the warning letter, the investigators observed serious violations of the Current Good Manufacturing Practices (CGMP) regulation for foods.

“This inspection revealed that food manufactured at your facility, including eclairs, Napoleon cakes, lemon mini cakes, and biscotti, is adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act (the Act) in that it was prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health,” according to the warning letter.

The following significant violations were noted:

• The firm failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. In addition to the presence of rodent excreta pellets, FDA inspectors observed a live rodent running across the east end of the production area, into the laundry room and into a hole in the wall at the northeast corner of the room; Additionally, thirty-seven apparent rodent excreta pellets were observed on and among unused equipment stored at the west end of the production room. “Apparent rodent excreta pellets too numerous to count were observed on a table top in the same area. The unused equipment can be a harborage for pests.”
• The firm failed to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. An employee was observed touching his face and then returning to handling ready-to-eat eclairs and cream filling without washing his hands. An employee was observed touching her glasses and then returning to packaging biscotti without washing her hands. An employee was observed handling biscotti with a bare hand that was bandaged. She was observed removing the bandage and continuing to package biscotti without washing her hands.
• The firm failed to clean all food-contact surfaces, including utensils and food-contact surfaces of equipment as frequently as necessary to protect against contamination of food. Apparent dough residue was observed on the dough sheeter after sanitation was conducted. The sheeter was last used to process cherry almond biscotti dough and is also used to prepare puff pastry, a dough that does not contain almonds.
• The firm failed to maintain building fixtures and other physical facilities of the plant in a sanitary condition and in sufficient repair to prevent food from being adulterated. Specifically, on Feb. 7, the interior of the stove hood was observed with a build-up of dust and debris directly above the stove and prep table where uncovered in-process foods are prepared. Employees were observed melting chocolate and gelatin, heating cream, and preparing blueberry topping on the stove directly below the hood.
• The firm failed to provide adequate and readily accessible toilet facilities maintained in a sanitary condition. In the men’s restroom, the floor was observed soiled in front of both toilets, the urinal, and both sinks. One of the toilets was observed soiled. A toilet brush was observed on the hand wash sink. No hot water was available at the hand wash sinks and no paper towels or hand drying device were observed. The trash can was observed with overflowing toilet paper tubes, used paper towels, and other waste.
• The firm failed to ensure the plant and facilities are constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair. Apparent black mold residue was observed on the wall and along the base of the window above the three-compartment sink in the production area. On the other side of the same wall in the laundry room, the wall appeared to be rotting and had an approximately two-inch hole in the wall. Additionally, stagnant, foul-smelling water was observed pooled in the trench drain near an unused walk-in cooler. The trench drain extended into the adjacent business and was not covered or screened, and, water was observed seeping from the west side to the east side of the walk-in cooler, where food was being stored.

Additionally, the FDA acknowledged a response letter, however the firm’s response to the above violations was not adequate, as further described in the letter.

Remnant Inc. DBA The Donut Stop
In a March 19 warning letter to company owner Randy H. Rodgers, the FDA described violations observed during an inspection on Dec. 4-7, 2017, at the firm’s donut manufacturing facility in Shenandoah, IA.

According to the warning letter, the firm was issued “Form FDA-483” for “Inspectional Observations” which documented insanitary conditions in the firm’s facility at the time of the inspection. Failure to manufacture foods in accordance with the CGMP requirements renders your firm’s food products adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.

Significant violations and observations included:

• The firm failed to perform filling, assembling, packaging, and other operations in such a manner that protects food from becoming contaminated. The investigator observed the firm topping finished product with nuts, an allergen, and immediately afterwards continue to frost finished product without washing hands or donning gloves. Our investigator also observed employees working with raw dough and handling finished product without washing handing or donning gloves. Employees were observed to touch hair face, glasses, and television remote during processing without hand washing.
• The firm failed to maintain finished food containers in an acceptable condition through appropriate cleaning and sanitizing. Specifically, the firm reuses visibly soiled cardboard containers to package finished donuts for delivery to wholesale customers. Allergen and non-allergen finished products are packed side by side in these boxes. Although plastic liners are used, they do not provide adequate barrier between the allergen containing finished product and non-allergenic containing product. Additionally, the cardboard boxes cannot be cleaned.
• The firm failed to handle work-in process to protect it from contamination. Specifically, the investigator observed uncovered dough being stored for further processing in the refrigerator in direct contact with the sides and back of the refrigerator where visible organic matter and debris was present.
• The firm failed to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food. Specifically, the investigator observed food debris and food residue on the sides and bottom of the proofer and raised uncooked donuts were directly touching the sides of the proofer; the belt on the dough sheeter that is used as a production line to add flavoring, shape and cut doughs was not cleaned or sanitized prior to production with visible flour build-up and residue; the dough cutter was not cleaned and sanitized prior to production and had build-up which appeared to be old dough; and the dough mixing bowl was observed being cleaned with an untested solution and wiped with a rag, and the bowl still had visible residue subsequent the cleaning process.

The FDA noted that this is a repeat observation from previous state of Iowa, Department of Inspections and Appeals, inspections.

• The firm failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition. Specifically, during the inspection our investigator observed visible holes and flaking and peeling paint in multiple areas of the ceiling in the production facility including an area above where in-process dough was stored uncovered; the ceiling fan observed to be in use in the production was covered in food dust and residue; this fan is located above the proofer, fryer, icing/frosting area, and finished donut holding area; the interior walls  throughout the facility were observed to be visibly soiled with food dust; the wall behind the ingredient storage area and next to the refrigerator had become separated from the exterior wall creating an approximately 3-4 inch gap between the walls; the gap was observed to be stuffed with newspaper and ingredient bags; additionally the wall behind the finished product boxes and cake donut frosting area had also become separated from the structure of the facility with a visible gap for accumulation of debris. This is a repeat observation from previous state of Iowa, Department of Inspections and Appeals, inspections.
• The firm failed to ensure all persons working in direct contact with food conform to hygienic practices while on duty to product against contamination of food by employees wearing suitable outer garments that protect against contamination of food. Specifically, the investigator observed employees using their bare forearms to transfer in- process dough from the dough sheeter to a wooden table for slicing and then onto the cracker cutting line. Additionally, personal belongings were observed in the production area in proximity to exposed food, such as tea, peanut butter, vitamins, and antacids.

To this date, the firm has not provided documentation that this any of the above observations are corrected.

Additionally, the FDA investigator collected labels associated with some of the products the firm manufactures during the inspection of the facility; “Based on our review, we have concluded that these products are in violation of the Federal Food, Drug, and Cosmetic Act.” Further observations and issues of “Misbranded Food” are described in the letter.

Bhavani Fruits & Vegetables LLC
In a March 16 warning letter to company president/co-owner Mukund N. Patel and company vice president/co-owner Chhaya Patel, the FDA described violations observed during an inspection from Oct. 11-30, 2017, at the firm’s produce warehouse in Maspeth, NY. According to the warning letter, the investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule.

“Based on FDA’s findings during the inspection we determined that your food products are adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act (the Act) in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health,” according to the warning letter.

The following significant violations are noted regarding the adulterated foods:

• The firm did not exclude pests from your food plant to protect against contamination of food.

“Specifically, during the inspection of your facility, FDA investigators noted evidence of bird and rodent activity. For example, our investigator observed apparent rodent gnaw holes on bags of rice located on the southeast portion of the ambient storage area and flour located in the Northwest corner of the ambient storage,” according to the warning letter.

Investigator also observed apparent rodent excreta pellets (REPs) too numerous to count both on and around as well as underneath the bags of rice. In addition, FDA investigators found rodent nesting material inside one of these bags.

“Moreover, our investigators observed one live mouse and several dead mice stuck to glue pads in your ambient storage area and in your walk-in cooler. Apparent REP’s were observed in multiple areas throughout the warehouse, including next to boxes of leafy green vegetables and on the floor next to boxes of spices, as well as next to spilled rice, underneath the counter where your firm’s microwave is located, inside the employee bathroom, and around a hole in the wall where the sewer line can be accessed.”

Investigators observed avian activity during the inspection. Specifically, on each day of the inspection our investigators observed four birds flying throughout the warehouse and landing on top of stored food products.

• The firm did not maintain their plant in repair adequate to keep food from becoming adulterated. Specifically, investigators observed an approximately 1 inch gap under your firm’s front rolling door while in the closed position and a hole of approximately 4 inches in diameter on the south facing wall of your firm’s ambient storage area.

“Additionally, the strip curtains in your firm’s rolling door were observed to be ripped, with some panels missing, allowing four birds to fly in and out of the facility. Finally, the strip curtains in your firm’s walk-in cooler were observed to be ripped, with some panels missing, which could allow birds and flying pests to enter the cooler area. The birds could land on and contaminate the fresh vegetables which may not be cooked by the consumer,” according to the warning letter.

• The firm did not store food under conditions that protect against deterioration and contamination. Specifically, our investigators observed several boxes of frozen peas and carrots and roti, stored on the floor in the walk-in freezer, wet with condensate from a broken fan and covered with an accumulation of ice (approximately 6 inches in height). Furthermore, the boxes were ripped and had already collapsed due to the ice condensate that formed on top.

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