Food Protection Trends - March/April 2021 - 189

coats, designated boots, hair nets, sleeve guards, and gloves.
Hand wash and boot dip stations were located adjacent to
the employee changing room. Additional boot dips and
hand dips were strategically located throughout the facility,
and the concentration of the sanitizer was tested by the
quality control manager. A nonalkaline detergent was used in
addition to an alkaline chlorinated foaming system. Peracetic
acid and a quaternary ammonium were used to sanitize
equipment. The flow of processing was done in one direction,
from ingredients to finished product, that minimized
potential cross-contamination of finished product. There was
a physical separation of the finished product processing area
from the other areas within the facility. Employee movement
was restricted by using area-specific designated employees.
Moveable equipment circulation was restricted by using areaspecific designated carts, pallet jacks, and trash receptacles.
Finished products were stored in a separate cooler. The
facility also had employee training upon hire and annually,
with topics including GMP, hazard analysis and critical
control point, chemicals, hand washing, food safety, Listeria
controls, etc. Environmental samples were collected weekly
from 10 sites on food contact surfaces and nonfood contact
surfaces from high-risk areas. The environmental samples
were analyzed for Listeria spp. by the quality control manager.
The investigator's review of the facility's own environmental
results for the previous 6-month period showed that Listeria
spp.-positive results were found on a wire cart, floor drain,
and slicer. The facility's documented corrective actions for
the wire cart and floor drain positives included aggressive
cleaning and sanitizing with disassembly and negative results
for retesting of the affected and surrounding areas. The wire
cart was eventually removed from service because it was
determined by the facility to be hard to clean. The slicer was
removed from service, aggressively cleaned and sanitized,
and then retested with 10 additional swabs. Two Listeria spp.
positives were also found by the firm from the area of (i) top
and bottom sprockets on the toothed feed belt (lattice area)
and (ii) platform. The lattice area was taken apart for more
intense cleaning and sanitizing followed by retesting with six
swabs that were negative. The next day the lattice area of the
same slicer was sampled (six swabs) after soaking the entire
unit in 200 ppm of quaternary ammonia solution, and five
swabs were positive. The lattice area was heat treated at 150°F
(65.6°C) for 2 h, and the retesting results were negative.
Group 2, insanitary conditions. Facility E had condensate
dripping onto a cooler floor near uncovered cooling coldsmoked fish. A hose with an affixed nozzle used to clean
food contact surfaces was stored on a wet floor, allowing
the potential for cross-contamination from the floor to food
contact surfaces. Dried food debris was on the blades of the
skinner and inside the grinder, indicating that the equipment
was not properly cleaned after use. Conveyor belts on the
finished product slicer were frayed and cracked, possibly
making them difficult to clean and sanitize.

Facility F had condensate dripping from the condenser
in the raw cooler in four different areas, creating four pools
on the floor near uncovered salmon (not smoked). Also, in
the finished product cooler there were two pools of standing
water. Pools of water and condensate on floors have the
potential to be contaminated with Listeria and to crosscontaminate wheels of moveable equipment, such as carts
and forklifts, which can spread contamination throughout the
facility. Additionally, when carts are pushed through pools
of liquid on floors there is the potential for splash to crosscontaminate any food or items being conveyed on the carts.
In this facility, the floors in the coolers and processing areas
were cracked and pitted. Floors in disrepair have the potential
to be difficult to clean and can create niches that harbor
Listeria. Employees in facility F were observed wheeling
garbage cans from the finished product processing area
outside to the dumpster and then returning through multiple
processing areas to the finished product processing area
without cleaning and sanitizing the equipment.
Facility H had a significant number of flies in the
processing room, and six flies were observed walking on
a preparation table. Flies can carry pathogens and crosscontaminate food, food contact surfaces, and equipment.
Group 3, environmental sample locations. Environmental
sample results from the five facilities in group 3 (I, J, K, L,
and M), which each had one swab with L. monocytogenes
detected, showed that L. monocytogenes was isolated from
drains, floors, and equipment in direct contact with the floor
in four of the five facilities. In the fifth facility, L. monocytogenes was isolated from a wooden cutting board used as a
food contact surface during packing of smoked fillets. This
facility (L) was re-inspected by FDA to evaluate the implemented corrective actions for the detection of L. monocytogenes on a food contact surface (i.e., the wooden cutting
board). The wooden cutting board had been discarded. Also,
during the re-inspection, FDA collected 10 subsamples of
cold-smoked salmon that were negative for L. monocytogenes
and the facility was found to be in compliance with CGMP
according to 21 CFR Part 110.
Group 3, insanitary conditions. In group 3, four of the
five facilities did not have any significant objectionable
observations during the inspection. The fifth facility (I) had
three CGMP deficiencies related to plumbing, floors, walls,
and ceilings that warranted voluntary action.
Group 4, facility N environmental sample locations. Results
of environmental sampling from facility N showed that
Listeria spp. were detected in 23 swabs from the 78 collected.
After further testing of the 23 Listeria spp. isolates, 11 were
found to be L. monocytogenes and 12 were nonpathogenic
Listeria species. Nonpathogenic Listeria species were isolated
from four legs of processing tables, two legs of brine tanks,
two brine tank drains, the bottom of a brine tank, the front of
a processing table, a strip curtain, and a metal basket on the
floor used to hold fish waste. L. monocytogenes was found in a

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Food Protection Trends - March/April 2021

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