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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Custom Seafood Services Inc. 3/26/12

  

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

Public Health Service
Food and Drug Administration
 Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA  98021-4421
Telephone:   425-486-8788
FAX:   425-483-4996 

 

March 26, 2012
 
 
CERTIFIED MAIL 
RETURN RECEIPT REQUESTED
 
In reply refer to Warning Letter SEA 12-18
 
Mr. John Phillips, Owner
Custom Seafood Services Inc.
206 South West Michigan Street
Seattle, Washington 98106
 
WARNING LETTER
 
Dear Mr. Phillips:
 
We conducted an inspection of your manufacturing facility located at 206 South West Michigan Street, Seattle, Washington on February 13, 14 and 16, 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, 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 Dungeness crab sections and King crab legs and claws are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby it 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 monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110 to comply with 21 CFR 123.11(b). However, your firm did not monitor for protection from adulterants with sufficient frequency to ensure compliance with the current good manufacturing requirements in 21 CFR Part 110 as evidenced by condensation continuously dripping from overhead pipes, electrical lines, metal vents and support beams onto finished, in-process King crab legs and Dungeness crab, open processing equipment and open containers of water and ice used in processing King crab legs and Dungeness crab. Dust accumulation, insect webbing, splattered crab waste, corrosion and peeling paint were also observed on the overhead pipes and lines.
 
We acknowledge your response letter, dated February 22, 2012, received by our office on February 23, 2012, responding to the Inspectional Observations (Form FDA 483) issued to you at the close of the inspection. A review of this letter found the response to be partially adequate. Your response to this observation is partially adequate in that you state you have adjusted the temperature to prevent excessive boiling. However, your response also states you have designed a system “to periodically wipe any condensation from piping above processing areas” but have not identified what “periodically” means, nor included a sanitation control measure for addressing condensation on overhead electrical lines, metal vents or support beams. Condensation on pipes and wires over the cookers has been observed and discussed with management in a March 23-30, 2006, FDA inspection. 
 
2.    You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take corrective action to control pathogen survival when your process for King crab sections deviated from your critical limit at the “Cook” critical control point. Your “Cook” CCP identifies a critical limit of an internal temperature of at least (b)(4)˚F and a cook time of (b)(4) minutes. Your monitoring step for this CCP identifies an internal temperature will be measure in at least (b)(4) crabs from each batch. Review of your processing records for King crab sections indicate the following deviations from this CCP occurred and no corrective action was taken:
 
a.    On February 1, 2012, the internal temperature for one of (b)(4) crabs tested in each of (b)(4) batches measured (b)(4)˚F.
b.    On February 9, 2012, the internal temperature for one of (b)(4) crabs tested in each of (b)(4) batches measured (b)(4)˚F.
c.    On February 1, 2012, (b)(4) batches of King crab sections received a cook of (b)(4) minutes.
d.    On February 2, 2012, one batch of King crab sections received a cook of (b)(4) minutes.
e.    On February 9, 2012, one batch of King crab sections received a cook of (b)(4) minutes and one additional batch of King crab sections received a cook of (b)(4) minutes.
 
In addition, your firm did not take corrective action to control pathogen survival when your process for Dungeness crab sections deviated from your critical limit at the “Cook” critical control point. Your “Cook” CCP identifies a critical limit of an internal temperature of at least (b)(4)˚F and a cook time of (b)(4) minutes. Your monitoring step for this CCP identifies an internal temperature will be measured in at least (b)(4) crabs from each batch. Review of your processing records for Dungeness crab sections indicate the following deviations from this CCP occurred and no corrective action was taken:
 
f.    On December 21, 2011, one batch of Dungeness crab sections received a cook of (b)(4) minutes and one additional batch of Dungeness crab sections received a cook of (b)(4) minutes.
g.    On December 22, 2011, one batch of Dungeness crab sections received a cook of (b)(4) minutes.
 
Review of your written response to this observation determined your response is partially adequate in that you state you have discussed the importance of these HACCP principles with your employees. However, you have not included in your response a statement to address how you will prevent these violations from recurring in the future. 
 
3.    You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure of recording the temperature of a minimum of (b)(4) sections from each batch at the “Cook” critical control point to control pathogen survival listed in your HACCP plan for Dungeness crab sections. A review of your processing records for Dungeness crab sections for January 12, 2012, and February 1, 2, 9 and 13, 2012, revealed two temperature readings were taken and recorded for (b)(4) batches. 
 
In addition, your firm did not follow the monitoring procedure of recording the temperature of a minimum of (b)(4) sections from each batch at the “Cook” critical control point to control pathogen survival listed in your HACCP plan for King crab sections. Review of your processing records for King crab sections for December 17, 2011, revealed one temperature reading was taken and recorded for (b)(4) of (b)(4) batches and for December 18, 2011, revealed one temperature reading was taken and recorded for all (b)(4) cook batches. 
 
Further, your firm did not follow the monitoring procedure of recording the temperature of a minimum of (b)(4) crabs from each batch at the “Cook” critical control point to control pathogen survival listed in your HACCP plan for whole Dungeness crab and review of your processing December 18, 2011, processing records for whole Dungeness crab revealed one temperature was taken and recorded for (b)(4) of (b)(4) cook batches. 
 
Review of your written response to this observation determined your response is partially adequate in that you state you have discussed the importance of these HACCP principles with your employees. However, you have not included in your response a statement to address how you will prevent these violations from recurring in the future. 
 
4.    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 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(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical of physical property that may cause a food to be unsafe for human consumption. However, your firm’s HACCP plans for whole Dungeness crab, Dungeness crab sections and for King crab sections do not list the food safety hazard of allergens. Both King and Dungeness crab are known to have proteins that are allergens.
 
Review of your written response to this observation determined your response is partially adequate in that you state in that you state you will make the appropriate changes to your HACCP plan to include a critical control point to address allergens “within the next 10 days”. Please provide a copy of your updated HACCP plans. 
 
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. 
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
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 and 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 Food and Drug Administration, Attention: Cynthia White, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issues in this letter, please contact Cynthia White at 425-302-0322. 
 
Sincerely,
/S/ 
Charles M. Breen
District Director