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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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L.A. Star Seafood Company, Inc. 6/14/13

  

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

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone:    949-608-2900
FAX:    949-608-4415 

 

WARNING LETTER
 
 
UNITED PARCEL SERVICE 
DELIVERY SIGNATURE REQUIRED                                                             
W/L 42-13
 
 
June 14, 2013
 
Sima Goldring, Owner
L.A. Star Seafood Company, Inc.
609 East 4th Street
Los Angeles, CA 90013-2105
 
Dear Ms. Goldring:
 
We inspected your seafood processing facility and importer establishment, located at 609 East 4th Street, Los Angeles, CA between May 7 and 15, 2013.  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 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 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). 
 
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4). 
 
Accordingly, your refrigerated ready-to-eat fishery products including cold smoked, such as whitefish, paddlefish, herring, mackerel, sprat, halibut, steelhead trout, salmon fillets and salmon bellies, and cured and pickled products, such as mackerel and herring, 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.
 
We acknowledge the receipt of your written response letter dated May 29, 2013.  We will address your response below, in relation to each of the noted violations. Your significant violations are 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 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, or physical property that may cause a food to be unsafe for human consumption."  However, your firm’s HACCP plan for (b)(4) does not list the following food safety hazards:
 
a.    Histamine formation. FDA has identified possible histamine formation in your exposed mackerel during the unrefrigerated processing steps in your operations.
b.    Pathogenic bacteria growth in your finished products during the processing and cold storage steps.
  
Please refer to Chapter 7 (Scombrotoxin (Histamine) Formation) and Chapter 12 (Pathogenic Bacteria…) of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition for guidance in determining the appropriate controls for your processing operations.
 
Your written response dated May 29, 2013 indicates that you were planning to update this HACCP plan by August 15th, 2013. This timeframe is unacceptable, and you should take immediate steps to create and implement adequate HACCP plans in order to produce safe products. Please address how your firm will correct these deficiencies immediately.
 
2.    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 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 (b)(4) lists critical limits at the (b)(4)  critical control point that are not adequate to control Clostridium botulinum. Your critical limits of (b)(4) and (b)(4) do not ensure that the thickest portion of your smoked fish will achieve an adequate amount of salt (i.e. 3.5% w.p.s.) to control the hazard. Furthermore, you do not have any scientific study or references to support that these critical limits are adequate, or have you conducted any finished product testing to determine if an adequate amount of salt is present based on your established plan.
 
Please refer to Chapter 13 (Clostridium botulinum toxin formation) of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition for guidance in determining the appropriate controls for your processing operations.
 
You explain in your May 29, 2013, written response that you were planning to update this HACCP plan by August 15th, 2013. This timeframe is unacceptable, and you should take immediate steps to create and implement adequate HACCP plans in order to produce safe products. Please address how your firm will correct these deficiencies immediately.
 
3.    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 a HACCP plan(s) for products processed by your firm, including but not limited to:
 
a.    Pickled (salt-cured) Herring to control the food safety hazards of Clostridium botulinum growth and toxin formation in uneviscerated fish during processing, histamine formation, and pathogenic bacteria growth due to time/temperature abuse.
b.    Vacuum packed cold smoked Herring to control the food safety hazards of Clostridium botulinum growth and toxin formation in fish during processing, histamine formation due to time/temperature abuse, and pathogenic bacteria growth due to time/temperature abuse.
c.    Vacuum packed cold smoked Escolar to control the food safety hazards of Clostridium botulinum growth and toxin formation in fish during processing, histamine formation due to time/temperature abuse, and pathogenic bacteria growth due to time/temperature abuse.
d.    Cold smoked Sprat to control the food safety hazards of histamine formation due to time/temperature abuse, and pathogenic bacteria growth due to time/temperature abuse.
 
Your written response dated May 29, 2013 does not address these violations.
 
4.    You must implement the monitoring, recordkeeping, and verification procedures listed in your HACCP plan, to comply with 21 CFR 123.6(b), 21 CFR 123.6 (c)(4), 21 CFR 123.6 (c)(7), and 21 CFR 123.8 (a) However, your firm did not follow your identified  monitoring procedures at the (b)(4) CCP, (b)(4) CCP, (b)(4) CCP, (b)(4) CCP, (b)(4) CCP or (b)(4) CCP listed in your HACCP plan for (b)(4). In addition, you do not maintain any records listed in the plan, or perform any verification (i.e. calibration of cooking equipment and thermometers) listed in this HACCP plan.
 
Your written response dated May 29, 2013 does not address these violations.
 
5.    Because you chose to include a corrective action plan 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 (b)(4) at the following critical control points are not appropriate:
 
For example,
 
a)    At the (b)(4) CCP, the corrective action is to (b)(4) These corrective actions do not ensure that the cause of the deviation is corrected to prevent future critical limit deviations, and that the affected product is not entered into commerce.
b)    At the (b)(4) CCP, the corrective action is to (b)(4). These corrective actions do not ensure that the cause of the deviation is corrected to prevent future critical limit deviations, and that the affected product is not entered into commerce.
c)    At the (b)(4) CCP and the (b)(4) CCP the corrective actions are to (b)(4). These corrective actions do not ensure that the cause of the deviation is corrected to prevent future critical limit deviations, and that the affected product is not entered into commerce.
d)    At the (b)(4) CCP, the corrective action is (b)(4).  This corrective action does not ensure that the cause of the deviation was corrected to prevent similar deviations from occurring in the future.
 
Your written response dated May 29, 2013 does not address this violation.
 
6.    You do not have or have not implemented written importer verification procedures, product specifications and an affirmative step(s) for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation, as required by 21 CFR Part 123.12(a)(2).
 
Specifically, you do not have written verification procedures, product specifications, or affirmative steps for any of the fishery products that you import from your foreign suppliers, including, but not limited to b(4) that you imported from the manufacturer b(4) b(4).
Your written response dated May 29, 2013 does not address this violation.
 
7.    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 A) Conditions and Cleanliness of Food Contact Surfaces and B) Protection From Adulterants with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by:
 
A.    Conditions and Cleanliness of Food Contact Surfaces:
 
1.    A cutting board used by an employee to trim unpackaged cold-smoked fish was observed with deep scored marks on both sides that were black/brown colored, and appeared uncleanable.
2.    Cutting boards used to eviscerate herring during the inspection were found to be deeply scored and uncleanable. These score marks were noted to have black/brown discoloration.
3.    The large green plastic vats used to hold herring during brining were observed to be dirty and uncleanable. Black, white and yellow-brownish residues and scoring marks were observed along the interior edges of the vats, and along the entire top ream surrounding the vats.
4.    Rusty handles were observed on the crate used to submerge into the herring brining tanks during processing.
5.    An uncleanable wood stick similar to a broom handle was being used to stir brined herring in large 55 gallon buckets.
6.    A 55 gallon plastic bucket being used to hold brine for processing was observed to have filthy residues along the top inner surface of the container, and on the container handles.
 
B.    Protection from Adulterants:
 
1.    Splash was observed from wet cleaning activities with a broom onto in-process, uncovered Sprats in the brining room were the cleaning was occurring.
2.    Metal fans (3) used to blow cool air onto in-process Sprats were observed to be dirty, with a buildup of dust on the fan blades and screens.
 
Your written response does not directly address these sanitation deficiencies.
 
8.    You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for any of the eight key sanitation conditions and practices required for the processing of (b)(4) products. 
 
Your response does not adequately address this violation, and states that you will begin monitoring sanitation at a later date. You must begin sanitation monitoring immediately, as required by the regulation as noted above.
 
We may take further action if you do not promptly correct these violations.  For instance, we may take further action to refuse admission of your imported fish and fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on “detention without physical examination”, seize your product(s) and/or enjoin your firm from further violating the Act. 
 
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 copies of any revised HACCP plans, at least five (5) product days’ worth of HACCP monitoring records to demonstrate that you have implemented the revised plans, any verification records, and 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.
 
Uneviscerated fish:
 
Please note that FDA strongly objects to the production and sale of uneviscerated fish that are salt cured, dried, or smoked (5 inches in length or over), as described in Compliance Policy Guide (CPG) Sec. 540.650 (copy enclosed). FDA considers these fish, and products made from such fish, to be adulterated per section 402(a)(4) of the Federal Food, Drug and Cosmetic Act, in that they been prepared, packed, or held under conditions whereby it may have become rendered injurious to health. These products are hazardous whether stored at ambient temperature, refrigerated, or frozen, or whether packaged in air, vacuum, or modified atmosphere. Because Clostridium botulinum spores are known to be present in the viscera, any product that will be preserved by salting, drying, pickling, or fermentation should be eviscerated prior to processing. Please consider this information when reassessing your current processing operations and when creating HACCP plans that use whole round fish as a raw material, including, but not limited to herring, mackerel and sprat.
 
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.
 
Your response should be sent to:
 
Mr. Blake Bevill
Director, Compliance Branch
U.S. Food and Drug Administration
Los Angeles District
19701 Fairchild Road
Irvine, CA 92612-2506
 
If you have any questions regarding any issue in this letter, please contact Robert McNab, Compliance Officer at (949) 608-4409.
 
 
Sincerely,
/S/
Alonza E. Cruse
District Director   
 
 
Cc:
 
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence