Inspections, Compliance, Enforcement, and Criminal Investigations
Cape Florida Seafood, Inc. 8/22/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
August 22, 2012
Terry R. Goldberg, President
Cape Florida Seafood, Inc.
7304 NW 34th Street
Miami, FL 33122
Dear Mr. Goldberg:
We inspected your seafood processing establishment, located in Miami, FL from May 23, 2012 to June 1, 2012. 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 (21 CFR Part 123). 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 tuna, salmon, and pasteurized crab meat products 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 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, your firm’s HACCP plan for Fresh Histamine Producing Fish does not list the food safety hazard of pathogenic bacteria growth and toxin formation (other than Clostridium botulinum) as a result of time and temperature abuse at the Processing/Butchering critical control point.1 Your plan specifies that “[on] occasion [,] fresh tuna may be eaten without cooking”.
2. You must have a HACCP plan that, at a minimum, lists the critical limits (CLs) that must be met, to comply with 21 CFR 123.6(c)(3). A CL is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your HACCP plan for Pasteurized Crab Meat lists a CL of (b)(4) at the Receiving CCP that does not specify the temperature throughout transportation to ensure the control of Clostridium botulinum toxin formation, and pathogenic bacteria growth and toxin formation (other than Clostridium botulinum) as a result of time and temperature abuse during transit.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each CCP, to comply with 21 CFR 123.6(c)(4). However,
a. Your firm’s HACCP plan for histamine producing fish lists a monitoring procedure (s)/ frequency at the receiving and storage CCPs that are not adequate to control histamine formation and pathogen growth due to time/temperature abuse. Your visual checks do not specify a representative number of containers to be observed for the adequacy of ice/frozen state of the cooling media.
b. Your firm’s HACCP plan for pasteurized crab meat lists a monitoring procedure (s)/ frequency at the receiving and storage CCPs that are not adequate to control C. botulinum and pathogen growth due to time/temperature abuse. Your visual checks do not specify a representative number of containers to be observed for the adequacy of ice/frozen state of the cooling media.
We received your response to the Form FDA 483, Inspectional Observations, issued to and discussed with you at the close of the inspection on 06/01/12. Your response does not adequately address the significant observations on the Form FDA 483.
Additionally, it is unclear which of your products are sold ready to eat. FDA is concerned that your salmon and tuna products may be at risk for parasite and pathogenic bacteria growth and toxin formation (other than C. botulinum) as a result of time/temperature abuse, respectively. Please refer to the Fish and Fisheries Products Hazards & Controls Guidance to amend your HACCP plans as needed to ensure the safety of your products. Please provide objective evidence in your response including but not limited to your amended HACCP plans to demonstrate that you adequately control these food safety hazards.
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 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). 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.
Emma R. Singleton
Director, Florida District
1 This deficiency is a similar deficiency to previous Observation 2(a) on the Form FDA 483, Inspectional Observations, issued on 11/16/10.