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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Scotty's, Inc.

  

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

Public Health Service
Food and Drug Administration
 

Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139

WARNING LETTER
2010-DT-02

November 9, 2009
 

VIA FEDERAL EXPRESS
 

Sandra J. Jackson/Owner
Scotty's, Inc.
3426 Junction Street
Detroit, MI 48210-3006
 

Dear Ms. Jackson,


The U.S. Food and Drug Administration (USFDA) conducted an inspection of your food processing facility on August 5, 7, 13, and 26, 2009. The inspection revealed insanitary conditions and violations of Title 21 of the Code of Federal Regulations (21 CFR) Part 110: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. The conditions observed cause the food products produced in your facility, including a variety of ready-to-eat sandwiches, 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 held under insanitary conditions. You can find the Act and the GMP regulations (21 CFR) pertaining to your firm at www.fda.gov. You were issued an FDA 483, at the close of the inspection, which lists the observations which were made. The observations cited in the FDA 483 fall into several main categories and will be discussed as follows:
 

PROCESS AND CONTROLS

Regulations which pertain to the manufacture, packing, or holding of human food specify that all reasonable precautions shall be taken to ensure that food production processes do not contribute contamination from any source. During the inspection of your firm, ready-to-eat whole peppers were observed stored uncovered on a cart in the walk-in-cooler: the paint on the shelves of the cart was peeling potentially contaminating the peppers or anything else that might be stored on the cart. This is a violation of 21 CFR 110.80(a)(1). The regulations further state that refrigerated foods are to be maintained at 45 F or below, as appropriate (21 CFR 110.80(b)(3)(i)). White turkey meat and cooked ham, both labeled "keep refrigerated" were observed left out in the slicing room for almost 5 hours at a temperature of 73.1 F. Containers of salad dressing and barbeque sauce were also observed left out in the processing room for an unknown amount of time at a temperature of 68.9 F. These conditions are described in the FDA 483, Observation #7.
 

During the inspection, employees of your firm were observed using cutting boards and spatulas, for the processing of ready-to-eat sandwiches of various types, which were deeply grooved and stained. Ready-to-eat sandwich buns and chicken salad sandwiches were observed in direct contact with the wall (a nonfood-contact surface) adjacent to the production table on which they were being processed. An employee was observed using a knife to cut open a cardboard box containing turkey bars and then using the same knife to cut one of the turkey bars into pieces without washing or sanitizing the knife. The following observations, which were recorded during this inspection, were repeat observations from the inspection in August 2008: unlined cardboard boxes were filled with ready-to-eat sliced bologna, plastic racks containing ready-to-eat buns were stored directly on the floor in the processing area, and an employee was observed placing a rack from the processing room floor directly on the production table in the processing room of ready-to-eat sandwiches. All of these observations are in violation of the regulation cited in 21 CFR 110.80(b)(2). They are presented in greater detail on the FDA 483, Observation #4, which you were issued at the close of the inspection.
 

EQUIPMENT AND UTENSILS

Equipment and utensils that are used in the manufacture, packing, or holding of human food are required to be adequately cleanable and properly maintained (21 CFR 110.40(a)). During the inspection, employees were observed using cutting boards and spatulas that were deeply grooved and stained, for the processing of ready-to-eat sandwiches (See FDA 483 Observation #4).
 

PERSONNEL

These particular observations deal with the practices of the employees in your firm as they perform their jobs. Specifically, employees were observed wearing unsecured jewelry which might fall into the ready-to-eat sandwiches that they prepare (FDA 483 Observation #13): this is a violation of 21 CFR 110.10(b)(4). Employees failed to wear beard covers when necessary (FDA 483 Observation #12): this is a violation of 21 CFR 110.10(b)(6) and is repeat observation from last year's inspection of your firm (August, 2008). Finally, employees store their personal belongings in areas where food is exposed and/or prepared (FDA 483 Observation #15): this is a violation of 21 CFR 110.10(b)(7) and is also a repeat observation from the inspection last year.
 

PLANT AND GROUNDS
 

According to the regulations (21 CFR 110.20(b)(4)) which pertain to the manufacture, packing, or holding of human food, the floors, ceilings, and walls of the physical plant in which your firm is located must be constructed in such a manner that they may be adequately cleaned, kept cleaned, and kept in good repair. During the inspection of your firm, ceiling tiles were found to be missing in several areas (walk-in-cooler, processing room, hall way), the walk-in-cooler compressor was leaking, and one of the ceiling tiles in the walk-in-cooler was contaminated with what appeared to be a black mold (FDA 483 Observation 5). The missing tiles in the processing area expose insulation material, pipes, and peeling paint where your ready-to-eat products are prepared. Your firm stores raw materials and ready-to-eat sandwiches in the walk-in-cooler where they are exposed to condensate from the compressor and possibly mold. All of these conditions are in violation of the good manufacturing practices (GMPs) which concern the production and handling of human foods.
 

SANITARY OPERATIONS
 

Two observations on the FDA 483 which you were issued concern the manner in which sanitary conditions are achieved and maintained in your firm. During the inspection, employees were observed placing ready-to-eat meat (bologna) on an unsanitized production table (Observation #8). This is a violation of 21 CFR 110.35 which specifies that all food-contact surfaces, including utensils and food contact surfaces of equipment shall be cleaned and sanitized as frequently as necessary to protect against contamination of food. Listeria innocua was detected in a swab from a plastic container under the hand washing sink in the meat slicing room.
 

Your firm is also required to exclude pests from food processing areas and protect against contamination of food by pests. During the inspection, live insect(s) were observed in a processing room on food, specifically, Turkey and Cheese sandwich with a sell by date of "AUG 312009". Insects were also observed flying around in the processing area where ready-to-eat sandwiches are processed (FDA 483 Observation #6). These conditions are in violation of21 CFR 110.35(c).
 

SANITARY FACILITIES AND CONTROLS
 

Your firm is required to provide and maintain adequate and accessible toilet facilities for employees. During the inspection of your firm, several conditions were observed which are in violation of these regulations (FDA 483 Observations 9, 10, and 11). Specifically, the male toilet facility was observed to be smelly and in a state of disrepair; there was no sign directing employees to wash their hands; the male female facilities lacked self-closing doors; and the female facility lacked running water of a suitable temperature. These conditions are in violation of the following regulations pertaining to firms which manufacture, process, or package human foods: 21 CFR 110.37(d)(1), (2), and (3) and 21 CFR 110.37(e)(1) and (5). Observations #10 and #11 are repeat observations of the inspection which occurred in August 2008. At that time, your firm's toilet facilities lacked self-closing doors and hand washing facilities with running water of a suitable temperature.
 

Your firm is also required to move, store, or otherwise dispose of trash to minimize odors, the attraction of pests, and to protect against the contamination of food, food-contact surfaces, water supplies, and ground surfaces. This is a regulation defined in 21 CFR 110.37(f). Your firm is in violation of this (FDA 483 Observation 14) because trash was observed on the floor near a production table where ready-to-eat sandwiches are processed.
 

SEAFOOD HACCP

This is the third time FDA has inspected your firm and has found that you process tuna salad sandwiches without having a HACCP plan to control the hazards associated with the processing of these products. The previous inspections were in August of 2006 and 2008. The first three observations of the FDA 483 which you were issued most recently concern seafood HACCP issues. Specifically, you do not have a written HACCP plan for tuna salad sandwiches to control the food safety hazards of histamines and pathogens. Also, your firm does not maintain sanitation control records for the production of tuna salad sandwiches that document monitoring and corrections in order to comply with 21 CFR 123 .11 (c); and no one associated with your firm has completed HACCP training or is HACCP qualified through job experience. During your discussion with FDA inspectors, you indicated that your firm would cease to process tuna salad sandwiches as of August 27, 2009. Please be advised that regulations (21 CFR 123.6(b), 123.11(b) and 123.10) require you to have a valid HACCP plan, appropriate sanitation procedures, relevant HACCP training, etc., for you to process seafood, including tuna fish salad sandwiches.

The above is not intended to be an all-inclusive list of violations. As a processor of human foods you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law. You should take prompt action to correct the violations described in this letter and establish procedures which will prevent them from occurring in the future.
 

You should notify this office, in writing, describing the corrective actions that you will take to bring your firm into compliance within fifteen (15) working days of receiving this letter. Your response should include each corrective action that you have or will take to correct these violations and prevent their recurrence. Please include copies of any documentation that demonstrates that the corrections have been. Your written response should be sent to Tina M. Pawlowski, Ph.D., Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If corrective actions cannot be completed within fifteen (15) working days of receiving this letter, please state the reason for the delay and the time frame in which they will be completed. If you have any questions concerning this letter, please contact Compliance Officer Pawlowski at (313) 393-8217 or bye-mail at tina.pawlowski@fda.hhs.gov.
 

Sincerely,

/S/

Joann M. Givens
District Director
Detroit District Office


Cc:
Michigan Department of Agriculture
Food and Dairy Division
Attn: Katherine Fedder
P.O. Box 30017
Lansing, MI 48909