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U.S. Department of Health and Human Services

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Enforcement Actions

Sunshine Peanut Company

   

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  555 Winderley Pl., Ste. 200
Maitland, FL 32751

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


WARNING LETTER


FLA-09-16


June 15, 2009


Jeff Turbeville, President
Sunshine Peanut Company
7405 Temple Terrace Hwy
Suite A
Tampa, Florida 33511


Dear Mr. Turbeville:


The Food and Drug Administration (FDA) conducted an inspection of your food
manufacturing facility, located at 57 Cantee Street, Jacksonville, FL 32204-1701 on
February 19, 20, 24 and 27, 2009. FDA investigators observed and documented serious
violations of the Current Good Manufacturing Practice (CGMP) regulations for foods,
Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). The inspection revealed
that conditions in your food manufacturing facility cause your food products to be
adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and
Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)], in that they have been prepared, packed or
held under insanitary conditions whereby they may have become contaminated with filth.
You can find the Act through links in FDA's homepage at www.fda.gov

The following significant deviations Were observed by our investigators during the
inspection:

>To comply with 21 CFR 11 0.35(c), no pests shall be allowed in any area of a food
plant; further, effective measures shall be taken to protect against the
contamination of food on the premises by pests. However, FDA investigators
observed the following visual evidence of your lack of pest control:

 

o Six (6) rodent excreta pellets (REPs) and a dead roach observed along the
north wall of the small room just outside of the walk-in cooler behind
pieces of equipment, boxes and cleaning supplies;


o At least twenty-eight (28) REPs, live spider with webbing, live roach and
a dead roach observed on and around a pallet stored with packaged jelly
and hot sauce and within close proximity to a bag of dry roasted peanuts
along the east wall approximately fifteen (15) feet north of the back
screened door in the processing area.


o In excess of fifty (50) REPs observed on the floor in the southwest comer
of building north of an opened/screen bay door by finished product
cardboard box storage and soy sauce label rolls. At least another forty four
(44) REPs observed on top of the cardboard box stack. Another three
(3) REPs observed on top of another pallet directly behind the first pallet.
A pallet of stabilizer ingredient for food production was stored within five
(5) feet of this rodent activity.


• In the same location as the forty-four (44) REPs, fluorescing stains,
characteristic of rodent urine, were observed under a black light
along the exposed cardboard boxes.


o In excess of thirty (30) REPs observed on the elevated edge of the
concrete loading platform of the northeast comer at the bay door and
located within approximately fifteen (15) feet of pallets of finished peanut
butter. A few additional REPs were observed approximately fifteen (15)
to twenty (20) feet down the platform closer to the food production area.


>To comply with 21 CFR 110.20(a)(1), you must properly store equipment,
remove litter and waste, and cut weeds or grass within the immediate vicinity of
the plant buildings or structures that may constitute an attractant, breeding place,
or harborage for pests. However, along the outside of the East wall of your
facility we observed overgrown grass, weeds, old equipment, empty drums,
pallets, and debris. In addition, on the South wall near the southeast comer, we
observed vines up and around the bay door (currently unused) to such a degree
that they grew through the door and were found inside of the building. These
vines inside of the building extend from approximately fifteen (15) feet up the
South wall within approximately one (1) foot of the floor on/around a metal rack
against that wall and tendrils are lying over a pallet of Veg amine cases on the top
shelf of this rack. This location is within approximately ten (10) feet of the jelly
production area.


>To comply with 21 CFR 110.20(b)(7), facilities must provide adequate screening
or other protection against pests. However, you did not provide adequate
screening or other protection against pests as evidenced by the presence of rodent
activity in your facility. Further, your rear entry door routinely maintains a
continuous gap due to a hose that leads to the outside of the facility. There are
holes along windows with no screens and gaps between the window frame and the
air conditioning unit in filling/packing area. There is a gap in the bay door with
an opening leading directly to the outside of the facility and a gap in the large fan
located near the labeling of finished product that leads directly outside the plant.
All of these openings may provide potential rodent entry in the facility.

>To comply with 21 CFR 110.10(b)(5), gloves used in food handling must be
maintained in an intact, clean, and sanitary condition. However, employees were
observed wearing gloves and performing various unclean tasks, such as handling
garbage, machinery, street clothing and touching their faces/noses, without
cleaning hands or changing their gloves,between operations.


>To comply with 21 CFR 110.10(b)(3), employees must wash their hands
thoroughly and sanitize in an adequate hand-washing facility before starting work,
after each absence from the work station, and at any other time when their hands
may have become soiled or contaminated. However, employees were observed
on two occasions not washing hands before returning to production:


o On 2/19/09, none of the employees washed or sanitized hands after
morning break.


o On 2/20/09, seven (7) out of nine (9) employees did not wash or sanitize
their hands after the morning break.


The above violations are not meant to be an all-inclusive list of deficiencies in your
facility. At the conclusion of the inspection, some additional deviations noted during the
inspection were listed on Form FDA-483, Inspectional Observations, and issued to Mr.
Bill H. Chen, General Manager. In addition, our investigators discussed these deviations
with you via teleconference on February 27, 2009. A copy of this form is enclosed for
your reference. It is your responsibility to ensure that all of your products are in
compliance with applicable laws and regulations. You should take prompt action to
correct all of the violations noted in this letter, discussed with you during the inspection
or which otherwise come to your attention. Failure to promptly correct these violations
may result in regulatory action without further notice, such as seizure and/or injunction.


You should respond in writing within fifteen (15) working days from your receipt of this
letter. Your response should outline the specific things you are doing to correct these
deviations. You should include in your response documentation, such as records or
photographs that document the corrective and preventive actions taken by your firm, or
other useful information that would assist us in evaluating your corrections. If you
cannot complete all corrections before you respond, please explain the reason for your
delay and state when you will correct any remaining deviations.

Please send your reply to the Food and Drug Administration, Attention: Brant Schroeder,
Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you
have any questions regarding any issue in this letter, please contact Mr. Schroeder at
(407) 475-4763.


Sincerely,

/S/

 

Emma R. Singleton
Director, Florida District

Enclosures:
Form FDA 483