Velvet Ice Cream Company Inc.’s ice cream manufacturing facility in Utica, OH, changed into inspected via the FDA from Jan. 23 to Feb. 14 and the outcomes had been not desirable. Lab checks showed the plant changed into harboring the pathogen Listeria monocytogenes. Environmental samples gathered on the facility at some stage in this year’s inspection back positive outcomes for the equal strain of the probably lethal pathogen inspectors observed during an FDA inspection in 2018. “During our inspection of your facility, FDA investigators determined severe violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation,” FDA’s East Division Director stated in a warning letter to the ice cream producer.
Based on the FDA’s inspectional findings and the analytical results for the environmental samples, the FDA determined that the ice cream manufactured inside the firm’s facility is adulterated in that it was prepared, packed, or held below unsanitary situations whereby it may have been rendered injurious to health. The following were amongst Velvet Ice Cream Company Inc.’s violations of the regulations for Hazard Analysis and Risk-Based Preventive Controls:
Firms are required to identify and implement preventive controls to provide assurances that any dangers requiring a preventive manipulate can be appreciably minimized or prevented, and the meals synthetic, processed, packed, or held by means of their facility will no longer be adulterated or misbranded; “In your meals safety plan, you identified environmental pathogens as a hazard requiring preventive controls and recognized sanitation controls to deal with the threat.
However, as evidenced with the aid of environmental findings that suggest a resident strain of L. Monocytogenes in your facility, you probably did now not implement sanitation controls ok to make sure that your facility is maintained in a sanitary circumstance to seriously minimize or prevent the threat of the environmental pathogen L. Monocytogenes.”
Nine environmental swabs accrued by FDA all through the maximum recent inspection have been superb for L. Monocytogenes; “Furthermore, environmental swabs accumulated throughout our 2018 inspection discovered L. Monocytogenes in nine swabs inside your facility and environmental swabs amassed at some point of our 2017 inspection discovered L. monocytogenesin three swabs inside your facility.”
Whole-genome sequencing (WGS) of isolates detected within the FDA environmental samples diagnosed twenty-one isolates representing six exclusive traces of L. Monocytogenes. In addition, the identical stress of L. Monocytogenes was identified in seven isolates from environmental samples collected at some point of the 2019 inspection and eight isolates amassed all through the 2018 inspection.
The FDA counseled the company of those WGS outcomes via a conference name on February 27, 2019, and the presence of the identical strain of L. Monocytogenes over a couple of years shows that there has been a resident pathogen or harborage web page of their facility because of 2018. Additionally, “that strain of L. Monocytogenes turned into genetically identical to at least one clinical isolate accumulated in 2018, which suggests this pressure has the functionality of causing human illness.”
These findings demonstrate that the firm’s sanitation strategies were inadequate to significantly decrease or prevent L. Monocytogenes from their facility. Furthermore, once L. Monocytogenes is hooked up in a manufacturing location, personnel or gadget can facilitate the pathogen’s movement and infection of meals-contact surfaces and finished product; “It is essential to become aware of the areas of the meals processing plant where this organism is capable of continuing to exist and grow to take such corrective actions as vital to get rid of the organism through rendering these regions not able to aid the survival and boom of the organism and prevent the organism from being re-established in such websites.”
The FDA acknowledged that the company has dedicated to appearing corrective movements in written responses which we obtained through the FDA on February 7, February 27, March 16, and April 24, 2019; “In your written responses, you imply which you have carried out a root reason analysis to become aware of the source of our findings, wiped clean and cleaned up your production environment, performed environmental swabbing to verify the effectiveness of your cleaning, and finished other sports with coping with the troubles.” The FDA mentioned that the company’s effectiveness in their corrective movements could be “demonstrated” at some stage in the FDA’s subsequent inspection.
The FDA additionally stated the following cGMP violations:
The firm did now not clean their non-meals contact surfaces in a manner, and as often as essential, to shield in opposition to contamination; “Specifically, on January 30, 2019, our investigators observed a worker the usage of an excessive-stress hose to spray the ground with water even as performing sanitation operations. They determined overspray from the floor onto device said as having been wiped clean and from the floor onto unopened buckets of elements that were going to be used to supply ice cream the following day.”
The company’s corrective motion shows that they may decrease the water pressure and retrain their personnel on the usage of water and easy up processes; “We will affirm the adequacy of this corrective movement at some stage in our next inspection.” However, the plant became not constructed and designed to facilitate the upkeep and sanitary operations; “Specifically, the layout of the production ground does no longer permit for the proper drainage of water. Water used in the cleansing of equipment pools in various places in the course of the production region of your facility, which can offer harborage regions for pathogenic bacteria inclusive of Listeria.”