New Delhi, November 20, 2017: The producer was asked to improve its use of Current Good Manufacturing Practices along with pest and safety controls after the FDA inspected one of its milk-based powder manufacturing facilities.
The US Food and Drug Administration (FDA) warned Kentucky-based Bluegrass Protein about issues it noted during an inspection of a production facility at the end of October. The initial inspections were completed in May and June according to feednavigator.com.
The investigation and additional analysis found the presence of the pathogen Salmonella, insect presence in feed products and violations to Current Good Manufacturing Practice (CGMP) for human food, the agency said.
“Based on FDA’s analytical results for the environmental samples and inspectional findings documented during the inspection, we determined that your food products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act,” said the agency.
During the inspection, pallets of dairy powders intended to be used in feed reportedly showed the presence of “beetle-like insects,” said the FDA. The insects were found within the shrink wrap and on the exterior of the products.
“During the inspection your firm’s management stated that the pallets were treated with a pesticide to contain the infestation,” the agency said. “The pallets were treated within the second floor warehouse where pallets of powder intended for human and animal food were also held.”
According to the reports published in feednavigator.com no records regarding how, when or what treatment was used were offered, the agency said. Crawling and flying insects also were found in different areas of the facility.
“Your firm failed to take precautions and restrictions when using insecticides to protect against the contamination of food, food-contact surfaces, and food-packaging materials and 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,” the agency said in the warning letter.
The company has told the FDA that in the future pest control activities will be recorded, reported the agency. However, that correction has not been documented.
Bluegrass also said that it has received an insect monitoring plan and taken steps including adding additional insect light traps, glue boards and pheromone traps, the FDA reported.
“Your firm’s response further states that all product stored in this area was destroyed on June 9, 2017, and that FDA investigators verified this during the exit interview,” the agency said. “However, on June 12, 2017, investigators observed new pallets of various dairy powders intended for use as animal feed with signs of active infestation with beetle-like insects, indicating that the insect problem was not addressed properly.”
Another area of concern mentioned regarded the lack of safety type light bulbs, fixtures or other suspended glass, said the agency.
“Pieces of a broken light shield were observed on the floor of the second floor warehouse near pallets of varied dairy powder intended for animal feed,” the agency said. “The light bulb was exposed.”
Again the company said it has addressed these concerns but did not offer documentation, said the agency.
Additionally, swabs taken from the facility found the presence of Salmonella, along with other facility concerns including water leaks and lacking temperature controls, the agency said. Cleaning procedures in some areas also needed additional instruction.
Feednavigator.com further added that the company was given 15 working days to respond to the letter regarding any additional steps that have been taken or that are planned to correct “noted violations” and prevent any re-occurrence, said the agency.
The company did not respond to a request for comment by press time.