For ease of reading, the contents of the FDA investigation were reprinted below. If you had to summarize it, one would say that the facility floors and equipment was not cleanable due to cracks and poor welds. Build up on equipment was noted and other procedures such as handwashing and sanitation were lax. Of course, Salmonella was discovered in environmental samples.
This is a good learning tool for facilities where post process contamination can be a concern.
OBSERVATION 1
Failure
to manufacture foods under conditions and controls necessary to minimize the
potential for growth of microorganisms
and contamination.
Specifically,
Two environmental sub-samples (INV
858387) collected on 7/16/2014 within Bakery ____ during tbe
manufacturing of dried pasteurized almonds lot 5461, were determined to be
positive for Salmonella. The locations of the sub-samples are listed below:Sub 175 Floor below cooling tower, east side, northern floor surface
Sub 188 Floor below cooling tower, west side, southern floor surface
OBSERVATION
2
Failure
to maintain equipment in an acceptable condition through appropriate cleaning and
sanitizing.
Specifically,
On 7/18/2014, food residues
were on the food contact surface of the discharge hopper on Roaster __ in Bakery __ The food residues were present on the equipment
during the pre-operation inspection of the equipment, after tbe equipment was
cleaned. The QC Manager confirmed the equipment was clean and ready for use.
OBSERVATION
3
Employees did not wash bands
thoroughly in an adequate hand-washing facility at any time their hands may have
become soiled or contaminated.
Specifically,
On 7/16/2014 an employee used
an electric pallet jack and then returned to transferring dried pastewized
almonds, lot 5461, from the discharge hopper to cardboard boxes using a blue
plastic bucket without washing their hands between the two operations. Their
hands were in direct contact with the top inside surface ofthe bucket, as well
as, the bottom of the bucket. The bottom of the bucket is in direct contact
with dried pasteurized almonds when the employees manually transfer dried
pasteurized almonds from the discharge hopper to cardboard boxes for cooling.
OBSERVATION
4
Food contact surfaces are not designed to
withstand the environment of their intended use.
Specifically,
On 7/21/2014 cracks in the
plastic were observed on six of the buckets inside of tbe cooling tower
attached to Roaster __ Each crack was approximately one half inch
long. On 7/22/2014 missing pieces of plastic were observed on two of the
buckets inside of the cooling towers in Bakery __ The largest
missing piece of plastic was approximately two inches by one inch. The plastic
buckets are in direct contact with roasted nuts when the cooling tower is in
operation. The plastic buckets are used to convey nuts into the cooling tower
cage from the discharge hopper and from the cooling tower cage to the super
sack.
OBSERVATION
5
Failure to have smoothly bonded or well
maintained seams on food contact surfaces, to minimize accumulation of organic
matter and the opportunity for growth of microorganisms.
Specifically,
The weld on the food contact
shovels for Roaster __and Roaster (b)(4) in Bakery
(b)(4) have rough welds. The weld attaches the shovel blade to the
handle. The shovels were in direct contact with roasted almonds during the
production of roasted almonds lot 5511. The shovels are used by employees in
the transfer of roasted almonds from the discharge hopper to the cooling tower.
On 7/21/2014, the screw auger was observed
out of the __ for cleaning. The weld on the food contact surface
of the screw auger for the REDACTION (b)(4) in the NA Jar Line had rough welds.
The screw auger conveys nuts from the in-feed hopper on the __
into the course mill for the production of nut butters. The screw auger is in
direct contact with the nuts.
The base of the cooling tower
cage for Roaster in Bakery is frayed and missing
pieces of metal. The cooling tower cage holds nuts in the cooling tower to
allow for air to cool the nuts prior to transfer into a lined super sack.
OBSERVATION 6
The procedure used for sanitizing
of equipment and utensils has not been shown to provide adequate sanitizing
treatment.
Specifically,
The
multi-range sanitizer used to sanitize food contact surfaces label states
non-immersed items must be allowed to air dry. nSpired Natural Foods Cooling
Tower Cleaning Instructions state, "Pressure wash interior and exterior
with sanitizer solution. Let sit for (b)(4) minutes then rinse off
with hot water.".
The plant is not constructed in such a
manner as to allow floors to be adequately cleaned and kept clean.
Specifically,
Throughout the facility, numerous
cracks and gouges in the floor were observed. Including, but not limited to, the
following:
A.
Four depressions, each approximately three inch diameter circles, in the NA Jar
Line room. The circular depression appear to be aligned with the feet of the
in-line metal detector.B. A two inch diameter circular depression in the floor of the NA Jar Line room. The circular depression appears to be aligned with the a foot of the filler.
C.
A three inch by three inch gouge is located in the southwest corner of the dry goods
warehouse.
D
. A crack in the concrete floor in Bakery approximately 15
feet long, parallel to the over-head door leading into the room.
E. A crack in concrete floor in Bakery
is greater than 20 feet long, perpendicular to the man-door
leading into Bakery. The crack in the floor continues from the
doorway, past the front ofthe dish wash sink, to underneath the storage racks.
OBSERVATION 8
Lack of backflow protection from
piping systems that discharge waste water.
Specifically,
On 7/21/2014, a hose was
submerged in the sink used to sanitize cleaned utensils. The sink used to sanitize
cleaned utensils contained a solution of sanitizer and water. The hose was connected
directly to the sink nozzle without backflow protection.
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