ECRS, LLC dba Big Chef 9/21/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Florida District 555 Winderley Place, Suite 200 Maitland, Florida 32751 Telephone: 407-475-4700 FAX: 407-475-4770

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-11-43

September 21, 2011

Rosana S. Calambichis
CEO/Co-owner
ECRS, LLC dba Big Chef
5839 Funston Street
Hollywood, FL 33023

Dear Mrs. Calambichis:

The United States Food and Drug Administration (FDA) inspected your seafood processing facility located in Hollywood, FL, from July 25, 2011, through August 10, 2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or 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) salmon pinwheels, RTE seared tuna canapé products, RTE cooked scallops with avocado salad canapés, and RTE surimi-based (imitation crab) canapés are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur 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 HACCP plans for the following products:

a. RTE refrigerated salmon pinwheels to control the food safety hazards of Clostridium botulinum growth and toxin formation and pathogenic bacteria growth-temperature abuse.

b. RTE refrigerated tuna canapes including but not limited to seared tuna with sprouts on wonton to control the food safety hazards of Clostridium botulinum growth and toxin formation; scombrotoxin (histamine) formation; pathogenic bacteria survival through cooking; and pathogenic bacteria growth due to temperature abuse.

2. You must have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(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,

 

a. Your firm's HACCP plan for "SCALLOPS COOKED" does not list the food safety hazards of pathogenic bacteria survival and toxin formation and pathogenic bacteria growth and toxin formation at the Cooking and Cooling Critical Control Points (CCPs), respectively.

b. Your firm's HACCP plan for "SURIMI (IMITATION CRAB)" does not list the food safety hazard of Clostridium botulinum growth and toxin formation at the Thawing CCP.

Additionally, it was noted during the inspection that your HACCP plans for "SURIMI (IMITATION CRAB)" and "SCALLOPS COOKED" do not include the CCP of finished product storage for controlling the food safety hazard of pathogenic growth and toxin formation.

We acknowledge your response dated August 15, 2011, to the Form FDA 483, Inspectional Observations, issued August 10, 2011. However, we deem it inadequate in that you failed to provide supporting documentation of your planned corrective actions. Your response primarily included that "All HACCP issues noted will be completed on or about October 10th 2011."

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), 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 send your reply to the U.S. Food and Drug Administration, Attention: Andrea H. Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Ms. Norwood by telephone at (407) 475-4724.

Sincerely,

/S/
Ronnie E. Jackson
Acting Director, Florida District
 

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