In a letter to Manilal Chandhari, manager, Sunrise Donuts, in Angola, Indiana, US, Glenn Bass, district director, Detroit District Office, found significant violations of the FDA’s (Food and Drug Administration) Current Good Manufacturing Practice (CGMP).
The FDA inspected Chandhari’s food processing facility from June 13-27, 2013, as part of the manufacturing, packing or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).
“These violations cause the foods manufactured at your facility to be adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health,” Bass reported.
Failure to maintain equipment
The investigator’s observations were presented to Chandhari after the 15-day inspection on June 27, 2013.
The worst of the approximately 17 violations found a failure to maintain equipment, utensils and finished food containers in an acceptable condition through appropriate cleaning and sanitizing.
Scrapers and spatulas used to make donuts were stored in brown liquid that appeared to be soiled water.
The liquid in the bucket was used to clean product residue off the scrapers and spatulas before and after use. The scrapers were used to scrape donut fillings from plastic buckets into a hopper that fills ready to eat donuts and the spatulas were used for icing donuts.
Metal spatulas were found in a bucket of water that appeared to contain a mold-like substance on the surface and inside the bucket. The metal spatulas in the bucket were used to ice donuts.
There were large dry pieces of yellow product residue on and in mixing bowls, and sticking to mixing paddles during the manufacture of donut dough.
The report found a failure to handle and maintain equipment, containers, and utensils used to hold food in a manner that protects against contamination and plastic bins used for mixing raw ingredients and mixing vat paddles were stored on a soiled floor.
Two bags of yeast inside a mixing bowl contained a batch of donut dough already in process. The shipping and receiving door remained open to the outside during the production of ready to eat donuts.
Flies on donuts
Bass said he saw flies on food contact surfaces including the mixers, cooling racks, utensils and production tables during production and on finished donuts.
An open bag of cake donut mix was stored directly on a soiled floor next to the mixing vat andsugared donut toppings were stored in uncovered tiered plastic trays.
There was no soap near hand washing sinks in the processing area and when an employee’s gloved hand touch the soiled floor while picking up a tray and donuts they resumed handling ready-to-eat donuts without washing their hands or replacing their gloves.
No-one wore hair nets and there was product build up on a wall directly above a stainless steel table to process donuts.
Rubbish was piled up on the floor in multiple locations in the processing area and there was product waste on the floor under a mixing vat.
Bass ordered Chandhari to take prompt action to correct the violations according to regulations administered by the FDA, otherwise he will be fined.