The labels of the Guava and Quesito pastries does not list milk which is a sub-ingredient of the cream
cheese used in the production of these two products. COS: The label was corrected to include the allergen, milk and
the client who received the last batch of products was contacted and supplied with the corrected labels. The labels of
several pastries containing various fruit filling (guava, strawberry, pineapple, apple) were missing the sub-ingredients
as listed on the containers of the fruit pulp. COS: The labels were corrected to include the sub-ingredients.
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117.10
Citation Description: Employee did not remove all unsecured jewelry and other objects that might fall into food
equipment,or containers,or remove hand jewelry that cannot be adequately sanitized during periods in which food is
manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be
maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by
these objects of the food, food-contact surfaces, or food-packaging materials. 21 CFR 117.10(b)(4)
Observation: Food processing employee was observed with multiple hanging necklaces in the fresh RTE baked
bread packaging area. Corrected action: PIC instructed the employee to remove jewelry. (COS)
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Print Date: 7/12/2022
Page 1 of 4
117.20(a)
Citation Description: Equipment not properly stored, litter and waste not properly removed, weeds or grass not cut
that may constitute an attractant, breeding place or harborage area for pests within the immediate vicinity of the plant
buildings or structures. 21 CFR 117.20(a)(1)
Observation: The outside area where products are received and shipped was observed with old equipment, unused
materials, wood pallets, overflow of cardboard boxes on the ground, junked golf car, and garbage. These constitutes
potential harborage conditions for pests.
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117.20(b)
Citation Description: Aisles or working spaces between equipment and walls are obstructed or are not of adequate
width to permit employees to perform their duties and to protect against contaminating food, food-contact surfaces,
or food-packaging materials with clothing or personal contact.. 21 CFR 117.20(b)(4)
Observation: Pallets of paper packaging and cardboard boxes in the dry storage area were not adequately spaced
to allow for employees to properly clean the area.
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117.20(b)
Citation Description: Adequate screening or other protection against pests not provided. 21 CFR 117.20(b)(7)
Observation: -The roll-up door was observed damaged with a large gap on the side. The screen door was observed
ajar and with small gaps. -The exit door, on the shipping and receiving area, was observed with a gap, large enough
for rodent entry. Corrected action: FE installed a weather strip at the bottom of exit door.
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117.20(b)
Citation Description: The plant is not constructed in such a manner as to prevent drip or condensate from fixtures,
ducts and pipes from contaminating food, food-contact surfaces, or food-packaging materials. 21 CFR 117.20(b)(4)
Observation: Condensate was observed dripping from an overhead unit in the quesito walk-in freezer, where frozen
RTE pastries and pastry ingredients were stored. Corrected action: Boxes were removed, and stainless steel pan
covering was placed. (COS)
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117.20(b)
Citation Description: The plant is not constructed in such a manner as to allow floors, walls, or ceilings to be
adequately cleaned and kept clean or to be kept in good repair. 21 CFR 117.20(b)(4)
Observation: The floor in front of the ice machine is cratered and allows the accumulation of gray water.
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117.35(a)
Citation Description: Buildings, fixtures and other physical facilities of the plant not maintained in a clean and
sanitary condition or kept in repair adequate to prevent food from becoming adulterated. 21 CFR 117.35(a)
Observation: There was an accumulation of dark water on the floor between the quesito walk in freezer and the
external wall, in this area there were small flies too numerous to count. -Flour residues were observed on pipes,
wires, and girders above the dough mixing area-Bread proofer room was observed with organic residues small flying
insects, apparent spider webs and condensate on the ceiling. Corrected action: Room was cleaned. -Brown liquid
was observed on the floor between the non-operating oven and external wall, next to to the fresh RTE baked bread
packaging area. Corrected action: Area was cleaned
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117.35(a)
Citation Description: Cleaning and sanitizing of utensils and equipment not conducted in a manner that protects
against allergen cross-contact and against contamination of food, food-contact surfaces, or food packaging
materials. 21 CFR 117.35(a)
Observation: -Organic black residues were observed inside bin of the ice machine. (Ice is used as an ingredient in
the dough) Corrected action:The ice was discarded and the bin cleaned.-Dried food residues were observed on
racks/trays on which pans with fresh RTE baked bread and frozen pastries are stored- Buildup of organic residues
observed on the floors in the quesito walk-in freezer and both dough chill blaster units - Several in process dough
pans and pastries that were held for cooling in the walk in cooler were observed covered with organic flakes and
particles.These products were discarded. -Dried food and black and pink organic residues were observed on both
frozen dough conveyor at the entrance and exit of the equipment. These were partially cleaned. -Dry food residues
were observed underneath the stainless steel table in the pastries processing area. Corrected action: The tables
were cleaned.
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117.35(c)
Citation Description: Effective measures are not being taken to exclude pests from the manufacturing, processing,
packing and holding areas and to protect against the contamination of food on the premises by pests. 21 CFR
117.35(c)
Observation: - Several black flies were observed in the packaging and baking area, in the pastries processing
areaand on pastries products. Partially corrected: Flies traps were installed. -Too many to count small flies were
observed in several areas including underneath the conveyor coming out of the frozen dough chill blaster , inside of
several pieces of unused equipment and behind the quesito walk in freezer .The affected areas were cleaned and
sanitized.-Live larvae were observed in condensate accumulations on the floor behind the small chill blaster. The
area was sprayed with chlorine solution.-- One live roach was observed underneath unused and filthy floor cleaning
equipment stored next to the dry storage of paper goods and cardboard boxes. Area was cleaned and sanitized
Roach like droppings were observed in the packaging storage area -Several black and shiny rodent like droppings,
along with brown rodent like droppings were observed under and between pallets of paper goods in the dry storage
area. In addition on the floor of the dry storage area, a dead black rodent was observed. PIC called pest control.
Also, the area was cleaned and sanitized.
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Print Date: 7/12/2022
Page 2 of 4
117.37(a)
Citation Description: Plumbing not adequate size and design or not adequately installed and maintained to provide
adequate backflow protection from piping systems that discharge waste water or sewage. 21 CFR 117.37(b)(5)
Observation: Several faucets throughout the food processing area were observed missing backflow prevention
devices.
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117.37(a)
Citation Description: Hand-washing facilities not adequate or convenient. 21 CFR 117.37(e)
Observation: -Observed missing hand sanitizer at handwashing sink where fresh RTE baked and RTE pastries are
made and packaged. -Employee handwashing sinks throughout the processing area were observed with food
residue encrusted inside basin and handles. Corrected action: All three handwashing sinks were cleaned. (COS)
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117.37(a)
Citation Description: Plumbing not adequate size and design or not adequately installed and maintained to provide
adequate floor drainage. 21 CFR 117.37(b)(4)
Observation: -Both air gap drainage of the 3-compartment sinks were observed draining slowly. -Water pooling was
observed in front the door of the quesito walk-in freezer and draining under the lifted metal ramp plate.
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117.37(a)
Citation Description: Plumbing not adequately sized and designed or not adequately installed and maintained to
avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary
condition. 21 CFR 117.37(b)(3)
Observation: A bucket was observed to collect water from an apparent leak on mop sink plumbing.
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117.37(a)
Citation Description: Conveyance, storage, or disposal of rubbish or offal does not minimize development of odor,
potential for waste becoming an attractant, harborage, or breeding place for pests. 21 CFR 117.37(f)
Observation: Accumulation of non-food utensils, personal items, filth, and debris were observed in the electrical
room located in the food dry storage creating possible harborage conditions.
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117.40(f)
Citation Description: Instruments and controls used for measuring, regulating, or recording temperatures, pH,
acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food not
accurate, precise and adequately maintained, and not adequate in number for their designated uses. 21 CFR
117.40(f)
Observation: There was no chlorine test strips available for checking the concentration of Chlorine sanitizer in the
ware wash sink and spray bottles.
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117.40
Citation Description: Design, materials, or workmanship of equipment or utensils does not allow adequate cleaning
or maintenance to protect against allergen cross-contact and contamination. 21 CFR 117.40(a)(1)
Observation: A deep crack was observed on the top marble table for cutting and assembling pastries. Also the ice
bin of the ice machine was observed with several cracks and breaks in the internal walls.
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117.4
Citation Description: Responsibility for ensuring compliance by individuals with the requirements of this part not
clearly assigned to supervisory personnel who have the education, training, or experience (or a combination thereof)
necessary to supervise the production of clean and safe food. 21 CFR 117.4(c)
Observation: There is no PCQI.
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117.4
Citation Description: Records documenting training of qualified individuals not available. 21 CFR 117.4(d)
Observation: Facility did not have any training records available to be review.
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