Heartland Gourmet, LLC 4/3/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Dr., Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100
April 3, 2013
RETURN RECEIPT REQUESTED
Ref. KAN 2013-8
Mr. Nathan Bell, Owner
Heartland Gourmet, LLC
Heartland Gourmet LLC
1700 Cushman Drive
Lincoln, NE 68512
Dear Mr. Bell:
Drug Administration (FDA)
inspected your manufacturing facility
located at 1700
Lincoln, NE 68512
. The inspection found
significant violations of FDA's Current Good Manufacturing
Practice (CGMP) regulations
in manufacturing, packing or holding human food, Title 21, Code of Federal Regulations,
10 (21 CFR Part 110). These
tions cause the foods manufactured at your
facility to be adulterated within the meaning of
4) of the Federal Food, Drug
, and Cosmetic Act (the Act)[21 U.S.C. § 34
4)] in that
they were prepared, packed,
or held under insanitary conditions whereby they
may have been
contaminated with filth
or rendered inj
to health. You can find
the Act and its implementing regulations on FDA
's home page www.fda.gov.
Specifically, our inspection of your facility revealed the following CGMP violations:
1. Your firm failed to take effective measures to exclude pests from processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). There was evidence of insect activity in and on food contact surfaces of the dry goods manufacturing equipment, where you manufacture products like your Gluten Free Double Chocolate Cookie mix and Gluten Free Chocolate Chip mix. Our investigators observed the following:
a. Five (5) dead and live apparent insects inside the sleeve connecting the hopper with the mixer of the stainless steel small mixer in the dry processing room.
b. A plastic tub located on the auger platform contained flour with apparent live and dead insects too numerous to count. When the plastic tub was moved, more apparent insects too numerous to count were discovered on equipment surfaces.
2. The design, construction, and use of equipment and utensils fails to preclude the adulteration of food with lubricants and contaminants, as required by 21 CFR 110.40(a). Specifically, on March 18, 2013, the following conditions were observed in the dry goods manufacturing area, where you manufacture products like your Gluten Free Double Chocolate Cookie mix and Gluten Free Chocolate Chip mix, that could lead to the contamination of product:
a. Stainless Steel (b)(4) large dry mix mixer in the dry mix room:
i. Rough and pitted seams on interior surfaces of manufacturing equipment
ii. Clear plastic tape was wrapped around equipment joints and seams.
b. Upstairs stainless steel hopper that feeds the large mixer in dry mix room:
iii. Clear plastic tape used to cover bad welds on stainless steel surface
iv. Opaque glue like substance was used to cover dark rough welds.
v. Rough, stained, and pitted seams on interior surfaces of manufacturing equipment
c. Small dry mix mixer with hopper in dry mix room:
vi. Rough and pitted bonded seams on interior corners of manufacturing equipment
vii. Clear plastic tape was wrapped around equipment joints and seams.
d. (b)(4) product packaging and conveyance equipment dry mix room:
viii. Clear plastic tape was wrapped around equipment joints and seams.
3. You failed to clean food-contact surfaces and utensils as frequent as necessary to protect against contamination of food, as required by 21CFR 110.35(d). Specifically, on March 18, 2013, the following conditions were observed in the dry goods manufacturing area, where you manufacture products like your Gluten Free Double Chocolate Cookie mix and Gluten Free Chocolate Chip mix, that contribute to cross-contamination between products and adulteration by non-production materials:
a. Stainless Steel (b)(4) Large mixer with hopper:
i. The equipment was identified as clean. However, this equipment has a significant build-up of product residues.
ii. Multiple surfaces displayed rough welds and seams that were pitted and stained.
iii. Clear plastic tape used to repair manufacturing equipment represents an un-cleanable surface.
iv. Deep scoring on the surface of the floor level auger's inner tube that appears to be a hard to clean surface
b. Stainless Steel Small mixer:
v. Vinyl sleeve connecting hopper with mixer exhibited staining and build-up of food residues. When the sleeve was released from mixer/hopper junction, approximately 5 dead and live apparent insects were discovered inside. Fatigue and discoloration of metal surfaces was observed under the sleeve.
vi. Use of clear plastic tape to repair and hold together manufacturing equipment
vii. Multiple surfaces that had rough welds and seams were pitted and stained.
viii. Manufacturing equipment in post operation clean status had significant build-up of product residues.
c. (b)(4) filling line:
ix. Belt displayed build-up of brown product residue over entire exposed surface
x. Clear plastic tape was used to repair manufacturing equipment. Tape was used to prevent motor housing oil leak from spilling into filling station.
xi. Mixer/Auger displayed build-up of product residues.
xii. Plastic tub located on auger platform contained flour with apparent live and dead insects too numerous to count. When the plastic tub was moved, more apparent insects too numerous to count were discovered on equipment surfaces.
4. You to failed store finished food under conditions that would protect against chemical contamination, as required by 21 CFR 110.93. Specifically, in the dry good manufacturing room, where you manufacture products like your Gluten Free Double Chocolate Cookie mix and Gluten Free Chocolate Chip mix, a bottle of sewing machine oil was stored on an uncovered and open shelf used to store ingredients for finished food. Also, in the dry goods manufacturing room, a clear plastic spray bottle with liquid, lacking label or content identification, was stored on the (b)(4), parts of which are food contact surfaces. The nozzle was pointing toward plastic sheets which makes the product container and is a product contact surface.
5. You failed to store personal belongings in an area where food is not exposed, as required by 21 CFR 110.10(b)(7). Specifically, on March 18, 2013, the following conditions were observed in the raw material storage areas used in your frozen dough products:
a. In the walk-in kitchen ingredient cooler, margarine was stored on a rolling rack uncovered. Employee beverages and food were observed in two different places in the cooler.
b. In the walk-in freezer, fruit filling and bread dough rolls were stored uncovered. Boxes containing various seafood items were observed being stored on the floor. Employee food was observed being stored in the freezer.
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products, injunction and/or prosecution.
We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter. Your response should include the specific steps you have taken to correct the violations. If you cannot complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of there-inspection and assessing and collecting there-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your response should be directed to
: Jessica E. Hensley, Compl
iance Officer, U.S. Food and
Drug Administration, Kansas City
8050 Marshall Dr.,
Suite 205, Lenexa, KS
. If you have any
questions, please do not hesitate to call CO
Hensley at (913) 495-5183
her an email at Jessica.email@example.com.
John W. Thorsky
Kansas City District Office
USDA FSIS, District 25
Room 985, Federal Building, Rm 985
210 Walnut Street
Des Moines, IA 50309
Nebraska Department of Agriculture
Food Safety & Consumer Protection
301 Centennial Mall South
P.O. Box 94947
Lincoln, NE 68509