Inspections, Compliance, Enforcement, and Criminal Investigations
Deli To Go, Inc. 25-Apr-05
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
April 25, 2005
John L. Vath, Jr., Owner
Deli To Go, Inc.
P.O. Box 876
Oldsmar, Florida 34676
Dear Mr. Vath:
On January 26, 28, and February 3, 2005, the United States Food and Drug Administration (FDA) inspected your facility located at the 1531 SW 5th Avenue, Ocala, Florida. During our inspection; our investigator found serious deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123) and Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (cGMP), Part 110 (21 CFR 110). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the fishery products 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). Accordingly, your ready-to-eat (RTE) tuna salad sandwiches are adulterated in that these products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health . You can find the Act, Seafood HACCP Regulations, and cGMP Regulations through links in FDA's homepage at http://www.fda.gov.
During our inspection, the investigator provided Doris Cabrera, Supervisor, with the form FDA 483, which presents her evaluation of your firm's performance regarding various aspects of the HACCP and CGMP requirements. Upon further examination of the information collected during the inspection, we found deviations from the principles of HACCP and the significant requirements of the program for your ready-to-eat (RTE) tuna salad sandwiches. Accordingly, on February 3, 2005, an amended form 483 was issued to and discussed with Lisa M. Mullaly, General Manager. The deviations of concern to us are as follows:
1. You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product that you process, and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123 .6(a) and (b) . However, your firm does not have a HACCP plan for ready-to-eat tuna salad sandwiches to control the food safety hazards of pathogen growth/toxin formation due to time/temperature abuse and Scombrotoxin (histamine) formation.
2. You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following sanitation condition and practices: cleanliness of food contact surfaces; prevention of cross-contamination; maintenance of hand-washing, hand-sanitizing, and toilet facilities; protection from adulterants; and protection of food, food packaging material, and food contact surfaces from adulteration with contaminants with sufficient frequency to ensure control as evidenced by observations made by our investigator during the inspection. Our investigator noted that food debris was present on rolling rack trays, heat sealing equipment, can racks, and shelving below processing tables. Additionally, our investigator observed failure of your firm to store raw materials, including dry ingredients, in a manner that protects against contamination. The investigator also observed a towel-wrapped leaking faucet on your three-compartment sink that was allowed to drip onto equipment and utensils. Also, the investigator observed that hand washing sinks in the food preparation/assembly area were inoperable, and no paper towels or soap were available at sinks in the processing area or restroom. Further, toxic cleaning compounds were observed in close proximity to dry gravy mix and on the assembly table used to package RTE products. Additionally, your firm was not taking appropriate actions to protect RTE products from pests. A dead mouse was also observed on a sticky trap underneath the shelving in the dry storage area, and empty card board/plastic boxes/cases were strewn about in the dry storage area, providing a breeding place/harborage area for pests.
3. You must maintain sanitation control records that, at a minimum, document monitoring and corrections, to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for all eight areas of sanitation required for the processing of high-risk, RTE tuna salad sandwiches, as observed by our investigator during the inspection . These eight areas include: 1) safety of water; 2) condition and cleanliness of food contact surface; 3) prevention of crosscontamination; 4) maintenance of hand-washing, hand-sanitizing, and toilet facilities; 5) protection from adulterants; 6) labeling, storage, and use of toxic compounds; 7) employee health conditions; and, 8) exclusion of pests.
In addition to the HACCP-related observations listed above, the FDA has also determined that your facility is subject to the registration requirements in § 415 of the Act, 21 U.S.C. § 350d, and our implementing regulation at 21 CFR Part 1, Subpart H. The Act and these registration regulations may also be found through links in FDA's homepage at the website listed above. During our inspection, your facility was not registered with FDA. Our records indicate that, to date, your facility has not been registered with FDA. The failure to register a facility as required is a prohibited act under § 301(dd) of the Act, 21 U.S.C. § 331(dd). We, therefore, request that you register your facility promptly. Registration may be accomplished on-line at http://www.access.fda.gov. If you have access to the Internet, FDA strongly encourages electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. You may also register by mail or fax using FDA's food facility registration form, Form 3537. This form can be obtained by calling 1-800-216-7331 or 301-575-0156 to inquire about mail or fax registration and related forms.
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.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation such as monitoring records, current seafood HACCP plans, or other useful information that would assist us in evaluating your corrections. If you cannot complete ail corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP Regulations, and the Current Good Manufacturing Practices Regulations for Human Food (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.
Please send your reply to the Food and Drug Administration, Attention: Diane J. Englund, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issue in this letter, please contact Ms. Englund at (407) 475-4741.
Emma R. Singleton
Director, Florida District