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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Caserio Gourmet, Inc. 06-Apr-05

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

Public Health Service
Food and Drug Administration


Atlanta District Office
68 8th Street, N.E.
Atlanta, Georgia 39309

April 6, 2005


Warniing Letter

Rosana F. Silva, President
Caselro Gourmet, Inc.
105 Hood Street, Bay #7
Durham, NC 27701-3704

Dear Ms. Silva:

On January 13-14, 2005, FDA conducted an inspection of your seafood processing facility located at 105 Hood Street, Durham, North Carolina. During our inspection, our investigator documented serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Tide 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). 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 to 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 Act, 21 U.S.C. 342(a)(4). Accordingly, your frozen shrimp croquets are adulterated, in that they have been prepared, packed, or hold under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and FDA's Fish and Fisheries Products Hazards and Controls Guidance:3rd Edition (i .e., the Hazard Guide) through links in FDA's home page at www.fda.gov.

The deviations of concern 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 and have a written HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for frozen shrimp croquets does not list the food safety hazard of pathogen growth and toxin formation at the "Cooking" and "Cooling" critical control points.

In order to reduce the likelihood for growth of food-borne pathogens of public health concern, such as Listeria monocytogenes, resulting from time/temperature abuse in cooked products, the Hazard Guide recommends an adequate cooking step, coupled with time and temperature controls during any post processing handling and/or storage that occurs prior to final refrigerated or frozen storage of the products.

While your firm's HACCP plan for frozen shrimp croquets lists a critical limit for Product (i.e., internal) Temperature of [redacted] F or above," at the "Cooking" critical control point there is no minimum corresponding cook time listed In our HACCP plan. Your cooking records Indicate that cook times range from [redacted] minutes to [redacted] minutes to achieve the Internal temperature of [redacted] F. The Hazard Guide suggests that firms continuously monitor the cooking temperatures for the duration of the cooking time to ensure achieving an adequate cook for the entire batch. In addition, your monitoring records should clearly demonstrate that the monitoring procedures/frequency have been followed and should contain the actual values and observations obtained during monitoring (e.g. actual temperature observed and when and how long it reached this temperature).

Your HACCP plan lists a critical control point for "Cooling" as "cooling product from [redacted] to [redacted] within hours or less" which is inadequate to control pathogen growth and toxin formation. The Hazard Guide recommends that products be cooled from 140°F to 70°F within 2 hours and cooled from 70°F to 40°F within an additional 4 hours.

In addition your firm's HACCP plan for frozen shrimp croquets does not Include a critical control point for the overnight cooler storage of the cooked/cooled shrimp filling necessary for controlling pathogen growth and toxin formation. The Hazard Guide recommends that during refrigerated storage, products be continuously maintained at e maximum storage temperature of 40°F, using an instrument capable of continuously monitoring the temperature. The Guide further recommends that firms conduct a visual check of the equipment daily to ensure that it is properly working and that temperatures have been properly maintained.

Chapter 12 of FDA's Hazard Guide provides guidance relating to how to avoid pathogen growth as a result of tirne/temperature abuse and Chapter 16 of the Hazard Guide provides guidance relating to how to avoid pathogen survival during cooking.

The FDA has also determined that your facility Is subject to the registration requirement in section 415 of the Act, 21 U.S.C. 350d, and FDA's implementing regulation at 21 CFR Part 1, Subpart H. During our Inspection at your facility, you were advised of this requirement . 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 ad under section 301(dd) of the Act, 21 U.S.C. 331(dd). Please register your facility Immediately.

Registration may be accomplished online at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. Alternatively. you may contact the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156 to inquiry about mail or fax registration and related forms.

This letter may not list all the deviations at your facility or label violations of those products within our jurisdiction . You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations, and the 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. We may take further action if you do not promptly correct these violations. For instance, we may recommend that the United States bring a legal action to seize your product(s) and/or enjoin your firm from operating.

Please respond in writing within 15 working days from your receipt of this fetter. Your response should outline the specific things you are doing to correct these deviations. You should Include In your response documentation, such as copies of the revised label, HACCP plans and HACCP monitoring records, or 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 state when you will correct any remalning deviations.

Please send your reply to Karen Y. Dodson, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, Georgia 30309. If you have questions regarding any Issue in this letter, please contact Mrs. Dodson at 404-253-1299.



Mary H. Woleske, Director
Atlanta District