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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Summerland Seafood, Inc. 26-Apr-05

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

Public Health Service
Food and Drug Administration


555 Winderley PI., Ste. 200
Maitland, FL 32751




April 26, 2005

John W: Ward, President
Summerland Seafood, Inc.
dlbla Key West Shellfish
P.O. Box 420223
Summerland Key, Florida 33042

Dear Mr. Ward:

On February, 17-18, 2004, the United States Food and Drug Administration (FDA) conducted an inspection your facility located at Mile Marker #25, Summerland Key, FL, 33042. We found that you have serious deviations from the Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, Title 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 otherwise operate in accordance with the requirements of 21 CFR Part 123, renders the processor's seafood 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 seafood products are adulterated, in that they have been prepared, packed, or held under insanitary conditions where by they may have been rendered injurious to health. You may find the Act and the Seafood HACCP Regulations through links in the FDA's home page at http:/www.fda.gov.

As note previously, during our inspection, the FDA investigator observed deviations from the Seafood HACCP regulations. The FDA Investigator provided your Vice President, Dawn M. Ward, with a copy of the Form FDA 483 (copy enclosed), which represents the investigator's evaluation of your firm's performance regarding various aspects of the HACCP requirements. The deviations were as follows:

1. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the refrigerated storage critical control point to control pathogen growth listed in your HACCP plan for cooked stone crab claws. There is no documentation pertaining to the cooking process of various batches of stone crab claws received between 2/3/05 and 2/8/05, and there is no documentation of the end of the cooking cycle for a batch of stone crab claws cooked on 1/7/05.

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: (1) safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice; (2) condition and cleanliness of food contact surfaces; and (3) prevention of cross-contamination from insanitary objects, as evidenced by observation of the following:

a) Two metal baskets containing cooked stone crab claws were transferred from the chilling tank to a rolling metal cart that previously had stored raw stone crab claws.

b) A metal basket containing raw stone crab claws was lifted over a cooking metal basket that contained cooked stone crab claws.

c) 'The orange/green plastic baskets that are used to handle graded cooked stone crab claws were not properly washed/rinsed/sanitized during the grading.

d) Two baskets containing graded cooked stone crab claws were stored in direct contact with a pallet that had not been washed. The baskets were transferred to a scale and then nested atop another basket containing cooked stone crab claws on ice.

e) Various fishermen were walking inside the ice room where the ice - that is used to re-ice cooked ready-to-eat stone crab claws - was in direct contact with the floor.

f) The stainless steel tank used to chill the cooked stone crab claws was not properly washed prior to adding the water/ice to chili the product. There was a shrimp inside the tank at the time the tank was being filled with water.

g) Two employees were not wearing beard nets during the grading process of cooked stone crab claws.

h) The grading table and the wooden boards that are used in the ice room have peeling paint.

3 . You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and you must have a written HACCPplan that list the critical control points, to comply with 21 CFR 123 .6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can, as a result, be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for smoked fish dip does not list the critical control point of receiving for controlling the food safety hazard of pathogen growth due to time/temperature abuse.

4. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR Part 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 firm's HACCP plan for fresh histamine species of fish lists a critical limit of <[redacted] degrees for [redacted] and "<[redacted] degrees afters [redacted] hrs" at the receiving and storage critical control points, which limits are not adequate to control histamine formation.

5. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for fresh histamine species of fish lists a monitoring procedure of "temp." at the receiving critical control point, which is not adequate to control the hazard of histamine formation.

6. Since you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for fresh histamine species of fish at the receiving and storage critical control points to control histamine hazards are not appropriate. The corrective action at the receiving critical control point is incomplete, and the corrective action at the refrigerated storage critical control point does not address corrections when the critical limits are exceeded.

In addition to the above-listed deviations, we also observed that your firm's HACCP plans for stone crab claws, smoked fish dip and fresh histamine species of fish list various inadequate verification procedures. Specifically, the verification procedures do not: (1) include the calibration of the cook clock; (2) address checking the temperature alarm for accuracy against calibrated thermometer at lest [redacted] per day; and (3) address the records review, quarterly histamine testing, and periodic measurement of internal temperatures of fish maintained at or below [redacted]° F. Also, your records do not include the date and time of the activity the record reflects and the signature and initials of the person performing the operation. Additionally, the thermometer of the small cooler where the fresh fin fish is stored was not working.

We acknowledge receipt of your firm's response, dated March 30, 2005, submitted to this office, by Dawn Ward, Vice President, in response to the Form FDA 483, issued to her on February 18, 2005. We have reviewed your response and it will be made part of the official file. The response is inadequate for the following reasons:

  • You did not include monitoring records in the documentation submitted for review.

  • The addition of the receiving critical control point to the Smoke Fish Dip HACCP plan was after the cooling critical control point instead of before the brining critical control point; moreover, if the critical limit is "fully refrigerated transport;" then the monitoring frequency must be continuous:

  • The pages of the HACCP plans are not numbered and identified, so we are unable to determine which pages go with which plans.

The above-identified deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all seafood products processed and distributed by your firm are in compliance with the Act and all requirements, of the federal regulations. Some of the above-mentioned deviations were previously pointed out to you in our letter dated February 13, 2002 (enclosed).

You should take prompt measures to correct these deviations. Failure to promptly correct the deviations noted may result in regulatory action without further notice. Such action includes seizure and/or injunction. In addition, FDA may detain your imported seafood products without examination. Under such conditions, FDA will not issue any Certificates for Export or European Union Health Certificates for any of the affected fish and fishery products processed at your facility.

Please notify this office in writing within 15 working days from your receipt of this letter of the specific steps you have taken to correct these violations including an explanation of each step taken to prevent their re-occurrence. Your response should include copies of any available documentation demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.

Your reply relating to these concerns should be directed to the Food and Drug Administration, Attention: Virginia L. Meeks, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32571. If you have questions regarding any issue in this letter, please contact Ms. Meeks at (407) 475-4731. We look forward to working with you to achieve a successful HACCP program.



Emma R. Singleton
Director, Florida District