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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Curry's Bakery Inc. dba Pastry Perfection 7/27/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
 
Telephone:      425-302-0340
FAX:    425-302-0402

 

July 27, 2012
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
In reply refer to Warning Letter SEA 12-27
 
Michael L. Curry, President
Curry’s Bakery, Inc., dba Pastry Perfection
5855 North Glenwood Street
Garden City, Idaho 83714
 
WARNING LETTER
 
Dear Mr. Curry:
 
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing firm located at 5855 North Glenwood Street, Garden City, Idaho, on June 6-12, 2012. During the inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food, 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 on 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 investigator observed the following evidence of a lack of pest control:

a.   At least 15 live insects inside your (b)(4) Dough Divider;

b.   At least two live insects inside the lower motor housing of your (b)(4) Table, at least  three live insects in encrusted flour and dough residue at the end of the (b)(4) Table, and at least ten live insects inside an unused electrical switch box attached to the (b)(4) Table;

c.   At least eight dead insects and insect webbing inside your Bun Rounder, in the recess areas on top of the top plate;

d.   One dead and one live insect inside a cardboard box containing 4 – 1 KG unopened bags of durum specialty flour stored in the Northwest corner of the production area; and

e.   Five dead insects on the inside and outside of cardboard boxes containing plastic bags of egg bread base.

We acknowledge the receipt of your written response dated June 26, 2012, to the FORM FDA-483, Inspectional Observations, issued to you at the close of the inspection. Your response to this observation is inadequate in that you state you have cleaned the areas where the insects were found and discarded the product on which insects had been observed. However, your response does not adequately address how you will prevent pests from entering your facility in the future. FDA recommends that you make pest control an ongoing priority. FDA will evaluate and verify all of your corrections during the next inspection.

2.   As required by 21 CFR 110.80(b)(1), you must maintain all equipment, utensils, and finished food containers in an acceptable condition through appropriate cleaning and sanitizing, as necessary. However, our investigators observed the following during the inspection:

a.   Accumulated dried caked dough and/or flour residue was observed on the following   utensils and pieces of production equipment:

i.   On the food contact surfaces of the belt assemblies of the (b)(4) Sheeters, the (b)(4) Table, and the Reverse Sheeter;

ii.   Inside the roller assemblies of the (b)(4) Sheeters and the (b)(4) Table, specifically between the main rollers and the scraper bars;

iii.   On food contact areas inside the (b)(4) Dough Divider and the top and bottom plates of the Bun Rounder;

iv.   On the blades of the cutter used in the production of your maple and chocolate bar doughnuts;

v.   On the bottom surface of the hub and hub mounting bolt heads of the (b)(4) Spiral Mixer and the (b)(4) floor mixers;

vi.   In the bristles and hand grip of a brush used to spread flour onto a work table during dough production;

vii.   In and on the handle grips of metal and plastic scoops, located inside metal bins that store flour, sugar, and milk whey ingredients; and

viii.   Inside and on the cutting blade of a can opener mounted on a work table in the production area.

b.   Utensils stored under a work table in the production area, identified by the Production Manager as clean and ready for use, were stored in a bucket with accumulated food debris.

We acknowledge the receipt of your written response to the FORM FDA-483, Inspectional Observations, issued to you at the close of the inspection. You indicate that this item has been corrected through employee education and the implementation of a written cleaning policy/schedule. However, your response can not be fully evaluated in that you have not provided the FDA a copy of the written cleaning policy/schedule or any evidence/documentation that the schedule has been implemented.

3.   As required by 21 CFR 110.80(b)(13), you must fill, assemble, and package food in a manner which protects food from contamination. However, on June 6, 2012, we observed the following: 

a.   An employee that was processing bagels touched her face with her hands and then resumed processing without first washing and sanitizing her hands; and

b.   An employee placed a plastic bucket onto a wet damaged section of the floor in the production area while carrying out production activities. Later, our investigators observed the same employee place this bucket onto the food contact surfaces of a work table in the production area without first cleaning or sanitizing the bucket.

We acknowledge the receipt of your written response to the FORM FDA-483, Inspectional Observations, issued to you at the close of the inspection. You indicate that this item is being corrected through proper training and employee education. The adequacy of your corrective actions and their implementation will be evaluated during our next inspection.

4.   As required by 21 CFR 110.80(b)(5), you must handle all work-in-process in a manner that protects against contamination. However, on June 6, 2012, we observed the following:

a.   The hand wash sink was used as a draining area for bagels just removed from their boiling water cook; and

b.   The three-compartment equipment sink countertop along the East wall was being used as a work area where cooked bagels were rolled in a Parmesan cheese coating prior to baking. The in-process bagels were uncovered and located within two feet of both the hand wash sink and the three-compartment equipment sink. 

We acknowledge the receipt of your written response to the FORM FDA-483, Inspectional Observations, issued to you at the close of the inspection. You indicate that the facilities for preparing bagels have been moved away from this area, and a separate area now exists that allows for the production of bagels without interference of other activities. The adequacy of your corrective action to these items will be evaluated during our next inspection.

5.   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 their hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility at any time when the hands may have become soiled or contaminated. However, our investigators observed production employees washing their hands in the three-compartment sink, with dishwashing soap and no towels because access to the hand wash sink in the production area was blocked by your bagel manufacturing operations.

We acknowledge the receipt of your written response to the FORM FDA-483, Inspectional Observations, issued to you at the close of the inspection. You indicate that the facilities for preparing bagels have been moved away from this area, and a separate area exists that allows for the production of bagels without interference of other activities. Additionally, your response indicates that you are training employees on hand-washing policies. The adequacy of your corrective action(s) to this item will be evaluated during our next inspection.

6.   As required by 21 CFR 110.80(a)(1), raw materials must be stored in a manner that protects against contamination. However, during the inspection the investigators observed the following:

a.   Metal trays containing crystal sugar, oatmeal, cinnamon sugar, granulated sugar, corn meal, and sesame seeds used in the production of several of your products were not in use and stored, uncovered, on a rack in the production area;

b.   Squeeze tubes containing lemon, apricot, apple, cream cheese, and apple chunk fillings were stored on a metal tray on the rack in the production area. Product was observed oozing from the squeeze tubes and comingling on the tray. Product appeared to have dripped on the sesame seeds stored on the tray below the filling tray; and

c.   Open boxes of shortening and margarine were stored, uncovered, in between the floor mixers in the production area.

We acknowledge the receipt of your written response to the FORM FDA-483, Inspectional Observations, issued to you at the close of the inspection. Your response indicates that you corrected these items at the time of the inspection. The adequacy of your corrective actions will be verified during our next inspection.

7.   As required by 21 CFR 110.40(a), you must maintain equipment so as to facilitate cleaning of the equipment. However, our investigators observed the following:

a.   One of the push button control caps of the (b)(4) Tech Spiral Mixer was damaged and torn, allowing residue to accumulate inside the cap such that it could not be easily cleaned;

b.   The end cap of the Reverse Sheeter was cracked and had been repaired with duct tape such that it could not be easily cleaned; and

c.   Two cloth bungee cords and a metal twist tie were used to repair the (b)(4) Sheeters. The cloth bungee cords and the metal twist tie are not easily cleanable.

We acknowledge the receipt of your written response to the FORM FDA-483, Inspectional Observations, issued to you at the close of the inspection. You indicate that for item 7.a. above, you removed the push button control caps. For item 7.b. you indicate that you have ordered a new part. Your response does not address item 7.c. Your response is inadequate in that you have not provided specific details on corrective actions you have taken or will take to prevent this violation from recurring in the future.

8.   As required by 21 CFR 110.35(d)(3), you must clean non-food contact surfaces of equipment as frequently as necessary to protect against contamination of food. However, our investigators observed the following:

a.   Accumulations of dried caked dough, flour, and/or oil residues on the exterior surfaces of production equipment, inside equipment housing areas of the (b)(4) Dough Divider, (b)(4) Table, Bun Rounder, and Dough Rounder, and on the push button control caps of the (b)(4) Spiral Mixer; and

b.   Accumulation of apparent mold or dirt on equipment surfaces such as the exterior lid and upper side surfaces of six closed plastic buckets containing various ingredients and re-work, stored in the walk-in cooler.

We acknowledge the receipt of your written response to the FORM FDA-483, Inspectional Observations, issued to you at the close of the inspection. You indicate that you have implemented a written cleaning schedule to ensure the equipment is cleaned and detailed in a satisfactory manner. However, your response can not be fully evaluated in that you have not provided the FDA a copy of the written cleaning policy/schedule or any evidence or documentation that such a schedule has been implemented.

9.   As required by 21 CFR 110.35(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 water dripping into the production area from the ceiling, from an approximate 1 foot hole in the ceiling, located next to a roof-mounted evaporative cooling unit. The drips were falling to the production area floor approximately 12 inches from a production table and approximately 3 feet away from one of the (b)(4) Sheeters. Uncovered insulation and hanging sheetrock at the ceiling were observed directly above the production table, which was used the night before to produce various pastries.

We acknowledge the receipt of your written response to the FORM FDA-483, Inspectional Observations, issued to you at the close of the inspection. You indicate that you have corrected this item by repairing the ceiling and cooler. However, your response does not provide documentation or evidence to support the corrections, nor does it address how you will prevent this violation from recurring in the future.  

10.   As required by 21 CFR 110.20(b)(4), plants and facilities must be constructed in such a manner as to allow floors and walls to be adequately cleaned and kept clean and in good repair. However, our investigators observed the following:

a.   Sections of the production floor, such as inside the entrance of the walk-in cooler, in front of the North wall (b)(4) floor mixer, and in between work tables, exhibited wear and deterioration causing exposed concrete and rock aggregate underneath, creating rough and pitted floor surfaces. Standing water and debris had accumulated in these areas; and

b.   Ice was extended into the walk-in cooler from the walk-in freezer, at wall seams and along the floor/wall juncture between the cooler and the freezer.

We acknowledge the receipt of your written response to the FORM FDA-483, Inspectional Observations, issued to you at the close of the inspection. Your response is partially adequate in that you indicated you have repaired the area that allowed cold air to permeate into the cooler from the adjoining freezer. Your response also indicates you have hired a contractor to make the repairs to the floor and that you are waiting for confirmation that the proposed fix will be acceptable and provide a long term solution. Until all corrections have been made, we are unable to verify the adequacy of the response. Please provide updated documentation that documents the floors have been repaired.

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.

You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to correct these violations may result in regulatory action without further notice, including seizure or injunction.

You should notify this office in writing, within 15 working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence.  You should include photographs and records, including pest control records and records of repair to equipment, and any other useful information to assist us in evaluating your corrections. If corrective actions cannot be completed 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 USC 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 the re-inspection and assessing and collecting the re-inspection fees [21 USC 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.

Please send your reply to the Food and Drug Administration, Attention: Brenda L. Reihing, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Brenda L. Reihing at (425) 302-0429.
                                                                             
Sincerely,
/S/ 
Charles M. Breen
District Director
 
 
cc: Idaho Department of Health and Welfare (IDHW)
       Patrick Guzzle, IDHW Food Protection Program Manager
       450 W. State St., 4th Floor
       P.O. Box 83720
       Boise, Idaho 83720-0036