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U.S. Department of Health and Human Services

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Enforcement Actions

East Bay Seafood Co., Inc. 6/14/13

  

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

Public Health Service
Food and Drug Administration
 New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781-587-7500
Fax 781-587-7556
 
WARNING LETTER
CMS # 398457
 
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
June 14, 2013
 
Mr. Hung Huynh
President
East Bay Seafood Co., Inc.
8 Seafood Way, Unit 1B
Boston, MA 02210
 
Dear Mr. Huynh:
 
We inspected your seafood processing facility, located at 8 Seafood Way, Unit 1B, Boston, Massachusetts from May 7, 2013 through May 17, 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, 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, raw, ready-to-eat tuna received, stored, processed, and distributed by your firm are adulterated, in that it has 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 firm’s response to the FDA Form 483, Inspectional Observations, issued at the conclusion to the inspection was received on June 4, 2013. Comments related to this response are included below.
 
Your significant violation was as follows:
 
  1. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, on May 10, 2013, your firm received a shipment of raw, ready-to-eat tuna where the product was not surrounded by gel packs. Your firm’s HACCP plan entitled, “Scombroid Species; Histamine: Source Control – Secondary Receiver” states the critical limit for receiving as “(b)(4).” Despite not meeting this critical limit, this shipment of raw, ready-to-eat tuna was still accepted by your firm. 
 
Your firm’s response to FDA Form 483 observation 1 states this HACCP plan will be revised to state the critical limit will be “(b)(4).” Your firm’s response is inadequate because a copy of the revised HACCP plan referred to was not provided to demonstrate how your firm will be monitoring this new critical limit.   In addition, your firm was observed receiving and accepting raw tuna which was outside the then-current critical limit.
 
  1. You must have a HACCP plan that, at a minimum, lists the critical limit 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 firm’s HACCP plan, entitled, “Scombroid Species; Histamine: Source Control – Secondary Receiver,” lists a critical limit of "(b)(4)" at the receiving critical control point. On May 10, 2013, (b)(4), thawed gel pack was observed to be inside each fish’s cavity during the receipt of a shipment of raw, ready-to-eat tuna by your firm. This shipment of product was still accepted and further processed by your firm. 
 
Your firm’s response to FDA Form 483 observation 4 states this HACCP plan will be modified to add “(b)(4)” to this critical control point’s critical limit. This response is inadequate because a copy of the revised HACCP was not included for review to demonstrate how your firm will be monitoring this critical limit.
 
  1. You must have a HACCP plan that lists the critical control points for each of the identified food safety hazards, to comply with 21 CFR 123.6(c)(2). A critical limit 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 entitled, “Scombroid Species; Histamine: Source Control – Secondary Receiver” does not list a critical control point for the step in the processing of raw, ready-to-eat tuna which occurs after receipt and before the processing step identified as “Storage,” a critical control point, in your firm’s HAACP plan. On May 7, 2013, a shipment of raw, ready-to-eat tuna was received by your firm and held at this processing step in a receiving area where the temperature was not continuously monitored. While held at this processing step for a period of approximately six hours, the temperature in this receiving area was observed to rise above 40° Fahrenheit. The processing step which involves the holding of received tuna during this stage in production is not identified in your firm’s HACCP plan as a critical control point to control histamine formation and other food safety hazards associated with raw, ready-to-eat tuna. You stated to our investigator raw, ready-to-eat tuna can be held at this processing step in this receiving area without continuous temperature monitoring for a cumulative of eight hours on some processing days. 
 
Your firm’s response states this HACCP plan will be modified to include “(b)(4)” as a critical control point. This response was inadequate because a copy of this revised HACCP plan was not included for review to demonstrate how your firm will be monitoring this new critical control point.
 
  1. You must implement the record keeping system that is listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm’s HACCP plan, entitled, “Scombroid Species; Histamine: Source Control – Secondary Receiver,” states a monitoring frequency of “(b)(4)” of the cooler temperature at the storage critical control point. The monitoring system utilized by your firm only records temperatures at (b)(4) intervals. This does not constitute continuous temperature monitoring to control the food safety hazards associated with this critical control point.
 
Your firm’s response to FDA Form 483 observation 5 states the continuous temperature monitoring devices for your firm’s coolers will now be taking temperatures at (b)(4) intervals. The response is inadequate because a copy of the revised HACCP plan was not included for review nor was evidence of the continuous temperature monitoring devices recording temperatures at these intervals.
 
  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, entitled, “Scombroid Species; Histamine: Source Control – Secondary Receiver,” does not list the food safety hazards of pathogenic bacteria growth and allergens as hazards to control. Raw, ready-to-eat tuna distributed by your firm is covered under this HACCP plan.
 
Your firm’s response to FDA Form observation 2 states “(b)(4).” Your firm’s response is inadequate because your firm did not include a copy of the revised HACCP plan to demonstrate how these hazards will be controlled.
 
  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 the following specific areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
 
  A.    Prevention of cross-contamination [21 CFR 123.11(b)(3)]
 
i.    Overspray from high-pressure hoses used on a cutting table and the floor in the processing room was observed contacting exposed, raw, ready-to-eat tuna
ii.    Pooling water was observed in the processing room approximately six inches away from exposed, raw, headed and gutted tuna on racks approximately six inches above the floor in a high foot traffic area
iii.    Ice which is used in direct contact with exposed, raw, ready-to-eat tuna was observed contacting the wall of the cooler, up to approximately eight feet from the floor.
 
In addition, your firm’s “Operational Checklist,” which is utilized as a monitoring record as part of your firm’s Sanitation Standard Operating Procedures (SSOPs), fails to document the safety of water and ice, prevention of cross contamination from insanitary objects, and protection of food/food contact surfaces from adulteration. 
 
Your firm’s response to FDA Form observation 7 states safety of water has been added to your firm’s operational checklist. Your firm’s response is inadequate because a copy of the operational checklist was not provided for review. Also, your firm’s response does not address the monitoring of prevention of cross contamination from insanitary objects, and protection of food/food contact surfaces from adulteration within your SSOPs. The corrective actions listed to address Warning Letter items 6A and 6B will need to be verified during the next inspection.   
 
  1. You must have a HACCP plan that includes ongoing verification activities including a review of any consumer complaint that has been received by your firm to determine whether the consumer complaint relates to the performance of critical control points or reveal the existence of unidentified critical control points, to comply with 21 CFR 123.8(a)(2). However, your firm did not perform such a review upon the receipt of consumer complaint number (b)(4) involving scombrotoxin poisoning. In addition, your firm’s HACCP plan does not list the performance of ongoing verification activities to include the calibration of process-monitoring instruments.
 
Your firm’s response to FDA Form 483 observation 9 states a customer complaint log will be maintained and verification activities will be modified to include the review of consumer complaints and calibration process of temperature monitoring devices. Your firm’s response is inadequate because your firm did not include a copy of the revised HACCP plan for review.  
 
Please refer to Chapter 7 of the Fish and Fisheries Products Hazards & Controls Guidance: Fourth Edition for additional information related to the hazard of Scombrotoxin (Histamine) Formation and the entire guide for general guidance regarding corrective actions.
 
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, 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 Food and Drug Administration, Attention: Todd Maushart, Compliance Officer, One Montvale Ave, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Compliance Officer Maushart at (781) 587-7578
 
 
Sincerely,
/S/ 
Darlene Almogela
Acting District Director
New England District