- Old Mill Bread Company
- Issuing Office:
- Seattle District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
October 17, 2014
In reply refer to Warning Letter SEA 15-02
Joe M. Hoopes, President
Old Mill Bread Company, Inc.
15708 Palatine Avenue North
Shoreline, Washington 98133-5918
Dear Mr. Hoopes:
The United States Food and Drug Administration (FDA) conducted an inspection of your bakery, located at 1102 NW 85th
Street, Seattle, Washington on September 3, 8 and 10, 2014. During the inspection, the FDA investigator documented serious violations of the Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). The inspection revealed that food stored at your facility is 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 the food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov
The serious CGMP violations noted during the inspection were outlined on a Form FDA 483, Inspectional Observations, issued to you at the close of the inspection. The violations observed included the following:
1. You failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically,
a. Two live beetle-like insects were observed crawling in accumulated dried bread dough debris inside the dough sheeter. One of the insects was confirmed to be a red flour beetle. The sheeter was actively being used to shape raw bread dough into loaves and bread dough that was exposed within approximately six inches of where the live insects were observed crawling in the sheeter.
b. At least 72 dead and live beetle-like insects were observed in accumulated flour inside a dough mixer bowl not currently in use. Some of the insects were confirmed to be carpet beetles and Mediterranean flour moths.
c. At least eight dead beetle-like insects were observed in accumulated flour on the floor adjacent to the dough mixer. Some of the insects were confirmed to be Mediterranean flour moths.
The sample INV 842486, collected during the inspection, was analyzed by FDA's Pacific Regional Laboratory Northwest. The analysis of this sample confirmed the presence of insects which had been collected inside the dough sheeter, inside the mixer and on the floor near the mixer. Insect species and parts identified included, but were not limited to, red flour beetles, cabinet beetle larvae, and Mediterranean moth cast larval skins, larval head capsules and cocoons. The visual observations and the analytical results for this sample confirm the presence of insect activity within your facility.
2. You failed to handle and maintain equipment, containers and utensils used to convey, hold and store food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). Specifically,
a. A metal rack holding at least (b)(4) loaves of freshly baked, cooling loaves of bread was observed stored directly next to greasy, soiled sheets of used cardboard in the southeast corner window of the bakery. The soiled cardboard was placed between the southeast window and bread rack to shade the bread from sun exposure. At least half of the bread loaves were stored within one inch of the soiled cardboard and at least one loaf of bread was directly touching the soiled cardboard.
b. At least (b)(4) loaves of freshly baked, cooling loaves of bread were observed stored directly on top large, used paper flour bags on a metal rack adjacent to the south wall.
c. At least (b)(4) loaves of freshly baked, cooling loaves of bread were observed stored directly on metal racks that were heavily soiled with approximately ¼-inch thick accumulation of grime.
d. A green plastic rack used to stack loaves of finished product was observed stored directly on the production room floor. Twenty-two of these green plastic racks were observed to have been stored overnight outside on the public sidewalk.
3. You failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food and food-contact surfaces, as required by 21 CFR 110.20(b)(6). Specifically,
a. Three floor fans were observed covered with approximately ¼-inch of accumulated grime blowing air directly onto cooling loaves of bread.
b. A ceiling ventilation duct directly above a wooden baking table was observed covered in dust and grime.
4. You failed to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination, as required by 21 CFR 110.35(d)(3). Specifically,
a. After cleaning, the dough sheeter contained chunks of dried dough below the sheeting used to form the bread dough. An accumulation approximately ¼-inch thick of dough, grime, pan spray and flour was observed on multiple sheeter components.
b. After cleaning, an accumulation approximately ¼-inch thick of grime was observed on the underside of the bread slicing machine.
c. An accumulation approximately ¼-inch thick of baked on grime was observed on the exterior of each baking pan and baking rack in the bakery that were used to manufacture bread products during the inspection.
d. After cleaning, an accumulation approximately ¼-inch thick of grime was observed on the milling machine in the milling room. Additionally, soiled duct tape was observed on the milling machine.
5. You failed to ensure that hair restraints were worn where appropriate, as required by 21 CFR 110.10(b)(6). Specifically, (b)(4) employees were observed in the production area mixing dough, shaping dough and packaging finished bread without wearing hair restraints.
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 regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. Please be aware that several of the above mentioned violations had also been observed during FDA inspections of your facility in May 2012 and June 2013.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
Additionally, Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s 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 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.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If the corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your written reply to Maria P. Kelly-Doggett, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have any questions regarding any issues in this letter, please contact Compliance Officer Maria Kelly-Doggett by telephone at 425-302-0427.
Miriam R. Burbach
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560