Inspections, Compliance, Enforcement, and Criminal Investigations
Bernhard's Bakery, Inc. 19-Nov-08
Department of Health and Human Services
Public Health Service
Cincinnati District Office
Via Federal Express
November 19, 2008
Mrs. Dianne Hoelmer, Owner
Bernhard's Bakery Inc.
518 York Street
Newport, KY 41071-1841
Dear Mrs. Hoelmer:
The Food and Drug Administration (FDA) conducted an inspection of your bakery located at 518 York Street, Newport, KY 41017-1841 on August 12-14 and 19-21, 2008. The inspection was conducted to determine compliance with FDA's Current Good Manufacturing Practice (CGMP) requirements for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). Our investigators documented serious deviations from the regulations that cause your ingredients and finished food products to be adulterated within the meaning of Sections 402(a)(3) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act)[21 U.S.C. 342(a)(3)(4)]. On September 16, 2008, our investigators participated in a follow-up visit to your premises with officials from the State of Kentucky. You can find the Act and the regulations through links in FDA's homepage at www.fda.gov.
Your significant violations are as follows:
1. You must inspect, segregate, and handle raw materials and other ingredients to as certain that they are clean and suitable for processing into food and stored under conditions that will protect against contamination, to comply with 21 CFR § 110.80(a)(1). In addition, appropriate quality control operations must be employed to ensure that food is suitable for human consumption. 21 CFR 110.80. However, investigators observed the following during the August inspection:
Live and dead insects in raw materials used for manufacturing goods at your firm, including four apparent larvae in a doughnut cake mix bag and numerous insects in devils food cake mix and chocolate cake mix bags
One dead insect in the metal flour bin and two live insects in the metal storage bin containing sugar
Live and dead insects in bins and bags containing raw materials such as flour, sugar, and mixes for donuts, devils food cake, and chocolate cake
A doughnut, intended for sale, that had a dead insect covered with glaze on a storage rack in the process of being taken out for retail sale
2. You must maintain all equipment, utensils, and finished food containers in an acceptable condition through appropriate cleaning and sanitizing, to comply with 21 CFR 110.80(b)(1). In addition, you must conduct all food manufacturing, including packaging and storage, under conditions and controls necessary to minimize the potential for contamination of food, to comply with 21 CFR 110.80(b)(2). Further, you must clean all food contact surfaces as frequently as necessary to protect against the contamination of food, to comply with 21 CFR 110.35(d). However, investigators observed the following during the August inspection:
One live and one dead insect in containers used to store clean baking trays, dead insects on the sheeter and dough divider, and eight dead insects on the shelves of the ingredient weighing station
Approximately 100 apparent rodent excreta pellets (REPs) near the pan washing area, REPs too numerous to count beneath the table in the sandwich preparation storage room, and approximately 65 REP's in the men's restroom/storage room
A dead mouse in a bucket near the pan washing area
Approximately sixteen live insects, including apparent cockroaches, were observed in storage bins containing baking trays and one live insect observed in a mixing bowl
3. You must maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and keep them in repair sufficient to prevent food from becoming adulterated, to comply with 21 CFR 110.35(a). In addition, you must not allow pests and must take effective measures to exclude pests from processing areas and to protect against the contamination of food by pests, to comply with 21 CFR 110.35(c). However, investigators observed the following during the August inspection:
A screen door in the receiving area and a screen door exiting to the street with gaps that could allow pests to enter your facility
Peeling walls (which could contaminate food or food-contact surfaces) and ceiling tiles with holes (which could permit harborage or passage of rodents or insects) throughout the bakery
Numerous observations of both live and dead insects and rodent activity, as described elsewhere in this letter, indicating that your firm's physical facilities are not being maintained in a sanitary condition or in repair sufficient to protect food from contamination
During the September 16, 2008 visit, our investigators observed that the ceiling tiles had been replaced since the August inspection. However, our investigators did not observe any repairs to the screen doors or peeling walls, and continued to observe live and dead insects in the production areas.
4. Fixtures must be maintained in a sanitary condition to prevent food from becoming adulterated (21 CFR§ 110.35(a)) and equipment must be used in such a manner as to preclude the adulteration of food with any contaminants (21 CFR § 110.40(a)). However, during the August inspection, investigators observed a can of PVC Primer and two cans of PVC Cement being stored on the bagel machine. The labels indicated that both products were toxic. Containers holding toxic substances should not be placed on or near food processing equipment in order to avoid adulterating food products.
5. Any person who appears to have an open lesion must be excluded from any operations which may be expected to result in contamination until the condition is corrected, to comply with 21 CFR 110.10(a). However, during the August inspection, investigators observed the bakery manager touching dough with an open lesion on his hand.
6. 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, to comply with 21 CFR 110.10(b). However, investigators observed the following during the August inspection:
An employee drinking a beverage in the production area and open personal beverage containers being stored near uncovered food in the walk-in refrigerator (21 CFR 110.10(b)(8))
Employees on multiple days working without hair nets and/or beard covers while handling food (21 CFR 110.10 (b)(6))
A personal jacket on trays near the pan washing area (21 CFR 110.10(b)(7))
7. In order to comply with 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, during the August inspection, our investigators observed Ammonia being stored in the production area.
During the August 2008 inspection of your facility, you voluntarily destroyed, under the State of Kentucky's supervision, raw materials and finished product found to contain live and dead insects. In addition, some of the observations from the August 2008 inspection have been found in previous inspections of your facility, including the failure to clean equipment and inadequate employee sanitary practices. We acknowledge observing several apparent improvements during our September 16, 2008, follow-up visit. However, your firm has not provided a corrective action plan addressing the violations noted in August and many conditions noted in our August 2008 inspection remain uncorrected, including the presence of insects. We strongly recommend that you determine the cause(s) of the pest infestation and take all necessary corrective actions.
You should provide a corrective action plan describing how you intend to eliminate the current pest infestation, how you intend to prevent the infestation from recurring, including any routine pest control service or program, and how you intend to prevent recurrence of the other deviations.
Failure to implement lasting corrective action on 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.
This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your food facility operates in compliance with the Act and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
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, actions performed to control the unauthorized entering 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 please include a timetable for the implementation of any remaining corrections.
Your written response should be sent to Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Parmon at 513-679-2700 Ext. 162.
Toniette K. Williams
Acting District Director
Cc: Mr. Tim Hoelmer, Bakery Manager
Bernhard's Bakery Inc.
518 York Street
Newport, KY 41071-1841
Mark M. Reed, Manager
Kentucky Food Safety Branch, HSICF
Health Services Building
275 East Main Street