It suspended the food facility registration of SM Fish Corp. of Far Rockaway, New York, because food from the plant may be contaminated with L. monocytogenes (Listeria).
Suspension of the registration means no food from the facility may be sold or distributed.
The agency also advised consumers to discard soups from Island Soups Company of New York with best before dates between July 2015 and June 2018 because they could be contaminated with Clostridium botulinum, a bacterium that causes botulism.
Flexing FSMA muscles
In the case against SM Fish Corp, the FDA used powers available through the Food Safety Modernization Act (FSMA).
Products were sold at the company’s seven retail outlets in New York and New Jersey (see recall here).
FDA’s decision to suspend the registration was prompted by a second inspection this year showing Listeria contamination throughout the facility.
An inspection from June 14 to July 6 resulted in 29 of 105 environmental samples testing positive for Listeria and some of these were adjacent to food contact surfaces.
FDA recommended that SM Fish recall certain ready-to-eat food products, which the company did and it ceased operating to revise cleaning and sanitation procedures.
The agency inspected the firm in 2015 and found Listeria in 15 of the 105 locations swabbed throughout the facility.
FDA re-inspected and re-sampled the facility from August 15 to September 9 this year finding the firm’s cleaning and sanitation procedures were unsuccessful in solving its environmental Listeria contamination.
The agency said ineffective cleaning and sanitizing procedures with the use of pressurized spray hoses and squeegees to move standing water into drains was of ‘serious concern’.
Testing showed Listeria in 12 of the 116 locations swabbed in the plant, including on a direct food contact surface.
Seven strains; one linked to four illnesses
Whole genome sequencing (WGS) matched some of the Listeria findings genetically to samples collected during the June/July 2016 inspection, as well as those from the 2015 inspection, indicating at least three strains have been consistently present during a two-year period.
WGS phylogenetic analysis found at least seven different strains of L. monocytogenes in the facility.
FDA collected environmental isolates from all inspections genetically identical to one strain that is a genetic match for the pathogen found in four listeriosis illnesses.
FDA will reinstate SM Fish’s food facility registration when the agency determines food produced by it no longer has a reasonable probability of causing illnesses.
Registrar Corp on inspections
When FDA initially inspects a facility, it is financed by the agency, but if it finds reason to re-inspect, the agency may charge re-inspections fees, according to Registrar Corp, a company which assists businesses with compliance to FDA regulations.
The FY 2017 hourly rates for FDA re-inspections are $221 per hour for domestic facilities and $285 per hour when foreign travel is required.
“For facility re-inspection fees, FDA will invoice the responsible party for the direct hours; including time spent preparing and traveling, at the appropriate hourly rate,” it said.
“It is crucial to prepare for possible FDA inspections in order to prevent costly re-inspections that may lead to the suspension of your food facility registration.”
Registrar Corp said it can assist facilities preparing for FDA inspections.
“A food safety specialist can perform mock FDA inspections at the request of both foreign and domestic facilities to help identify any potential problems and help facilities to better understand FDA’s expectations.”
Island Soups and FDA
Meanwhile, in a different investigation FDA said safety concerns related to Island Soups Company extend to low-acid canned products with best before dates mentioned above.
FDA inspected the company in June and determined the facility does not meet mandatory safety requirements for thermally processed low-acid canned food (LACF) products.
Failure to adhere to these requirements can result in under-processed foods, which can allow survival and growth of C. botulinum, said the agency.
The company said soups are under review by the FDA and cannot be in supermarkets until this is complete.
After a July 2015 inspection, Island Soups Company signed an affidavit saying it would cease production and distribution until it met regulatory requirements but FDA said, to date, it has not filed scheduled processes for the products.
The company also continued to distribute soups to online customers in March and June this year which triggered the follow-up inspection in June.
Following this inspection the firm said it would contract a co-packer to manufacture soups that would file scheduled processes, maintain processing records, conduct container integrity examinations and address violations identified.
At the end of August, FDA required the company get a written “emergency permit” from the agency. An emergency permit may be required when FDA finds, after investigation, a commercial processor has failed to fulfill requirements for LACF products.
Island Soups Company recalled six varieties of soups in September because they have potential to be contaminated with C. botulinum. To date there have been no confirmed reports of illness.