Food Protection Trends - March/April 2021 - 190

brine tank drain, in the bottom of a brine tank, on two legs of
processing tables, in five areas on the floor, and in two floor
drains in the processing areas.
Group 4, facility N insanitary conditions. Totes used to keep
fish immersed in the brine solution were soiled and stored
on the wet floor. Totes constructed with holes in the bottom
used for holding fish were placed on cardboard that had been
previously stepped on by employees. The fans used to dry
the fish after brining were visibly dirty. There was rust on
the ceiling in the walk-in cooler above exposed stored fish.
A box of salt used during brining of the fish was stored on top
of a floor drain. All of these sanitation issues were corrected
before the inspection was completed. The firm did not have
any procedures for environmental sampling.
Group 4, facility O environmental sample locations (initial
inspection). Environmental sampling results from facility
O showed that Listeria spp. were detected in 12 swabs from
the 78 collected. After further testing of the 12 Listeria
spp. isolates, 10 were found to be L. monocytogenes and 2
were nonpathogenic Listeria species. L. monocytogenes was
detected on (i) a paddle used to agitate thawing fish, (ii) the
bottom rack of a cart in the brine cooler, (iii) a brine tank
drain spout, (iv) the exterior door handle on the smoker
cooler, (v) the rubber strip on the interior of the brine cooler
door, (vi) the rubber grip areas on the top handles of two
step ladders (brining area), (vii) the front and (viii) rear
forklift wheels (thaw area), (ix) the exterior strip along the
base of the thaw room door, and (x) a rope attached to the
thaw room door used to lower the roll-up door.
Group 4, facility O sanitation controls (initial inspection).
Facility O had ozonated water for thawing fish, quaternary
ammonium hand dips, fogs for equipment, foot dips, foaming
floor sprays, peracetic floor wash, quarterly employee
training, an environmental testing plan for Listeria spp.,
and finished product testing for L. monocytogenes. The
investigator's review of the facility's own routine weekly
environmental sampling over a 10-month period prior to the
inspection showed that Listeria spp. were detected on two
separate sampling dates from the floor in the brining room
and the floor near a freezer. The firm's corrective actions
included cleaning with chlorine solution, steam cleaning, and
sanitizing with quaternary ammonia solution, followed by the
collection of additional swabs over three consecutive days.
The firm's results showed that Listeria spp. were not detected
in the swabs taken after this intense cleaning and sanitizing.
Group 4, facility O insanitary conditions (initial inspection).
During the inspection, investigators observed poor employee
practices. For example, employees sprayed and cleaned
brining bins in a manner that generated splash and spray,
which contacted the floor near fish that was ready to enter the
smoker; this created the potential for cross-contamination
from the floor. Carts of packaged finished product were
stored under cooling units that were dripping condensation.
An employee was observed dragging their smock across

190

Food Protection Trends March/April

the finished product processing floor for several feet while
leaving on break.
Group 4, facility O first re-inspection. Facility O was reinspected due to the detection of L. monocytogenes on a
food contact surface (the bottom rack of a cart in the brine
cooler holding exposed salmon fillets on above racks).
During the re-inspection, the firm provided information on
their corrective actions for the previous inspection, which
consisted of cleaning and documentation of sanitation
improvements. Additionally, the FDA investigators observed
employees handling processing clothing properly without
contacting the floor, and the cooler had been reorganized
to prevent product from being stored under the cooler unit
where dripping condensation was previously observed. The
firm also replaced their totes with disposable totes, replaced
drain covers in the fish fillet area, added additional foot dips,
sanitized brining utensils, and started periodically spraying
step ladders with chlorine.
Additional environmental sampling conducted by FDA
showed that L. monocytogenes was detected in 8 swabs of the
96 analyzed. L. monocytogenes was isolated from (i) a rubber
grip area on the top handle of a step ladder in the brine area,
(ii) a taped area on the top handle of a step ladder in the
brine area, (iii) a rubber strip on the base of the brining room
door, (iv) a wheel of a pallet jack, (v) a paddle with rivets
used to stir brine, (vi) an in-floor scale in the fillet area,
(vii) the front wheel of a pallet jack in the RTE food
processing area, and (viii) rack surfaces in the finishing cooler.
Finished product samples collected by FDA were found to
be contaminated by L. monocytogenes. The firm voluntarily
recalled the product. PFGE conducted by FDA showed that
the L. monocytogenes isolated during the initial inspection
was indistinguishable from the isolate obtained during
the first re-inspection. This indicates that the facility's
cleaning, sanitizing, and corrective actions were not
sufficient to eliminate the pathogen and a resident strain
of L. monocytogenes was established in the facility. These
results also suggest that the rubber grip and taped areas on
the step ladders may have been difficult to clean surfaces
that created niches for the harborage of L. monocytogenes
and that the firm's corrective action of periodically spraying
the step ladders with chlorine did not eliminate the
pathogen. The PFGE conducted by FDA also showed that
L. monocytogenes isolated from the finished product was
indistinguishable from the environmental samples. This
indicates that the contamination most likely occurred from
cross-contamination within the facility.
Group 4, facility O second re-inspection. A second re-inspection was conducted because FDA detected L. monocytogenes
in environmental and finished product samples during the
first re-inspection. Once again, FDA evaluated CGMPs, collected environmental and finished product samples, verified
sanitation and process changes since the first re-inspection,
and reviewed the firm's environmental testing records. The

Food Protection Trends - March/April 2021

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