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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hillcrest Bakery Inc. 7/10/09

   

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996


July 10, 2009


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


In reply refer to Warning Letter SEA 09-23


Robert J. Kaskes, President
Hillcrest Bakery, Inc.
10010 Main Street
Bothell, Washington 98011


WARNING LETTER


The Food and Drug Administration (FDA) conducted an inspection of your bakery
located at 10010 Main Street, Bothell, Washington, on April 16, 17, and 20, 2009.
During the inspection, the FDA investigators documented serious violations of the
Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of
Federal Regulations
(CFR), Part 110 (21 CFR 110). These violations cause the food
products produced in your facility to be adulterated within the meaning of Section
402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act),
in that they have been prepared, packed, or held under insanitary conditions whereby
they may have become contaminated with filth or rendered injurious to health. You can
find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov.


Your significant violations are as follows:


1. As required by 21 CFR 110.35(c), you must not allow pests in any area of a food
plant. Effective measures must be taken to exclude pests from the processing areas
and to protect against the contamination of food on the premises by pests.
However, our investigators observed the following evidence of a lack of pest control:


a. One dead rodent was observed on the floor under a rack located against
the south wall of the dry storage ingredient area.
b. Large numbers of rodent excreta pellets (REPs) were observed
throughout your firm.


i. REPs were observed on the inside bottoms of plastic storage bins
containing bags of the ingredients, some of which were open,
used to manufacture bakery products.
ii. REPs were observed under metal racks in the dry storage
ingredient room.
iii. REPs were observed on shelves next to paper bags used to
package ready-to-eat foods.
iv. REPS were observed at the floor/wall juncture in the dry storage
ingredient room.
v. REPs were observed on the floor under the processing table in
the production area.


2. As required by 21 CFR 11 0.80(b)(1), you must maintain all equipment, utensils, and
finished food containers in an acceptable condition through appropriate cleaning and
sanitizing, as necessary. In addition, in order to comply with 21 CFR 110.35(d), you
must clean all food-contact surfaces, including utensils and food-contact surfaces of
equipment, as frequently as necessary to protect against the contamination of food.
However, our investigators observed the following during the inspection:


a. A bowl, not cleaned and sanitized before use, was observed with thick
product residue on the inner food contact surface while being used to
measure flour to make bread.
b. A bucket, not cleaned and sanitized before use, was observed with thick
product residue on the inner food contact surface while being used to
hold poppy seeds, an ingredient used in your bakery products.
c. A bowl, not cleaned and sanitized before use, was observed with thick
product residue on the inner food contact surface while being used to
measure raspberries, an ingredient used in your bakery products.
d. A mixing bowl, not. cleaned and sanitized before use, was observed with
thick product residue on the inner food contaCt surface while being used
tq mix dough for making doughnuts.
e. A metal sifter, not cleaned and sanitized before use, was observed with
thick product residue on the inner food contact surface while being used
to measure cocoa powder.
f. A substance that appeared to be mildew was observed on the inside door
panel of the proof box.


3. As required by 21 CFR 110.35(b)(2), toxic cleaning compounds, sanitizing agents,
and pesticide chemicals shall be identified, held, and stored in a manner that
protects against contamination of food, food-contact surfaces, or food-packaging
materials. However, our investigators observed the following during their inspection:


a. Paint, gasoline, and cleaning compounds were stored on a rack directly
next to food packaging materials in the dry storage area.
b. Liquid board cleaner was stored next to black pepper in the production
area.
c. Liquid detergent was stored on a windowsill above a sink, adjacent to a
container of artificial maple flavoring.

4. As required by 21 CFR 11 0.40(a), all equipment and utensils must be designed and
of such material and workmanship as to be adequately cleanable, and shall be
properly maintained. The design, construction, and use of equipment and utensils
must preclude the adulteration of food with any contaminants. However, our
investigators observed the following during the inspection:


a. The wooden processing table in the production area had a metal
base plate screwed onto the surface. The metal base plate was not an
easily cleanable surface and was observed to contain old product
residue. Holes along the vertical sides of this same wooden processing
table also contained thick product residue.
b. The inside door panel of the proof box was damaged, resulting in a large
gap that could not be easily cleaned.
c. Duct tape was applied to processing equipment and to the door of a
cooler. The surfaces on which duct tape was applied could not be
effectively cleaned.


5. As required by 21 CFR 110.20(b)(5), you must provide safety-type light bulbs,
fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass
breakage. However, our investigators observed·that three light fixtures in the dry
storage area, and six light fixtures directly over processing tables where ready-to-eat
bakery products are manufactured in two production areas, were not shielded or
shatterproof and that food was not otherwise protected against contamination in
case of glass breakage. One of the unprotected ceiling lights was located directly
over 12 open bags of flour and sugar, ingredients used to manufacture ready-to-eat
bakery products.


6. As required by 21 CFR 11 0.35(a), you must maintain buildings, fixtures, and other
physical facilities in a sanitary condition and keep them in repair sufficient to prevent
food from becoming adulterated. However, our investigators observed the following
during the inspection:


a. The floor/wall juncture in the back production area, under the sink and
dishwasher, contained product residue and trash.
b. The floor area in between the oven and the proof box contained product
residue and trash.


7. As required by 21 CFR 110.80(b)(7), equipment, containers, and utensils used to
convey, hold, or store food must be handled in a manner that protects against
contamination. However, our investigators observed that food storage containers
were stored on an old wooden rack located in the sink next to the dishwasher. This
may cause these containers to become contaminated because wood is a porous
material that harbors bacteria and cannot be effectively cleaned.

8. As required by 21 CFR 110.10(b)(3), all persons working in direct contact with-food,
food-contact surfaces, and food-packaging materials must wash hands thoroughly
(and sanitize if necessary to protect against contamination with undesirable
organisms) in an adequate hand-washing facility at any time when the hands may
have become soiled or contaminated. However, our investigators observed the
following during the inspection:


a. While weighing ingredients, one processing employee was repeatedly
observed touching metal weights covered with old product residue and
then immediately handling dough to make bread without first washing or
sanitizing his hands.
b. Employees were observed touching the surfaces of equipment to which
duct tape was applied, which could not be easily cleaned, and then
touching product without first washing or sanitizing their hands.
c. Outer surfaces of plastic containers used to hold bakery ingredients
contained thick product residue. Employees were observed touching
these surfaces and then using their hands to mix bakery ingredients for
various bakery products without first washing or sanitizing their hands.


9. As required by 21 CFR 110.10(b), all persons working in direct contact with food,
food-contact surfaces, and food-packaging materials must conform to hygienic
practices while on duty to the extent necessary to protect against contamination of
food. However, our investigators observed the following during the inspection:


a. One employee was observed eating chocolate chip cookies and drinking
soda in the production area while pies were being produced; three
personal drink containers and one orange were observed on a production
table. Eating food and drinking beverages must be confined to areas
other than where food may be exposed or where equipment or utensils
are washed (21 CFR 110.10(b)(8)).
b. Personal clothing, specifically a soiled and frayed jean jacket, was
observed hanging on a door' in the processing area, and one employee
was observed wearing this same jacket when walking in and out 'of the
freezer to assemble ingredients for production of a bakery product.
Clothing or other personal belongings must be stored in areas other than
where food is exposed or where equipment or utensils are washed (21
CFR 110.10(b)(7)).
c. Three employees were observed in the production area without hair nets
while icing cake and packaging bread, and three additional employees
were observed without hair nets while mixing ingredients and baking
various bakery products. Effective hair restraints such as hair nets or
headbands must be worn where appropriate and in an effective manner
(21 CFR 110.10(b)(6)).


This letter may not list all the violations at your facility. You are responsible for ensuring
that your food facility operates in compliance with the Act and the Current Good
Manufacturing Practice regulations (21' CFR Part 110). You also have a responsibility
to use procedures to prevent further violations of the Act and all applicable regulations.


Failure to implement lasting corrective action of these violations may result in regulatory
action being initiated by FDA without further notice. For example, we may take further
action to seize your products and/or enjoin your firm from operating.


We request that you notify this office in writing, within 15 working days from your receipt
of this letter, of the current status of your corrective actions and the specific steps you
have taken to correct the noted violations. In your response, include documentation
such as certification of actions performed by a licensed exterminator, other actions
performed to control unauthorized entrance of pests, plans on how you plan to protect
food products from possible contamination, and/or any other useful information that
would assist us in evaluating your corrections. If you cannot complete all corrections
before you respond, we expect that you will explain the reason for your delay and state
when you will correct any remaining violations.


Please send your reply to the Food and Drug Administration, Attention: Lisa M. Althar,
Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have
questions regarding any issue in this letter, please contact Lisa Althar at (425) 483-4940.


Sincerely,

/S/

Charles M. Breen
District Director

cc: WSDA with disclosure statement