Inspections, Compliance, Enforcement, and Criminal Investigations
Stagnaro Bros Seafood Inc 8/23/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda. CA 94501 -7070
Telephone (510) 337-6700
VIA UNITED PARCEL SERVICE
Our Reference: FEI No. 2937521
August 23, 2012
John L. Tara, President
Stagnaro Bros. Seafood, Inc.
320 Washington Street
Santa Cruz, California 95060
Dear Mr. Tara:
We inspected your seafood processing facility, Stagnaro Bros. Seafood, Inc., located at 320 Washington Street, Santa Cruz, California, on June 18, 20, 22, 26, and 27, 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 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 refrigerated vacuum packaged ready-to-eat smoked fish, refrigerated histamine forming fish such as tuna, refrigerated, canned, cooked ready-to-eat crabmeat, and refrigerated, canned raw scallops 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 receipt of your July 13, 2012 facsimile letter and attachments in response to the FDA 483 List of Observations. During the FDA inspectional close-out meeting, you also provided our investigator your firm’s Hazard Analysis Worksheet and HACCP plan for “Dung. Crabmeat, Scallops (Oxygen Restricted)” dated June 27, 2012. The deviations listed in this warning letter are based on the inspection, our evaluation of your HACCP plan for “Dung. Crabmeat, Scallops (Oxygen Restricted),” and our review of your July 13, 2012 response letter.
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 plans “Freezer vacuum pac, cooked, ready to eat, smoked fish,” “Ahi, Blue Fin, Tombo, Albacore, Mahi, Ono,” and “Dung. Crabmeat, Scallops (Oxygen Restricted)” do not list the food safety hazard of allergens. FDA has identified allergens as a food safety hazard and must be included in your HACCP plans.
To establish the appropriate critical limits, monitoring procedures, corrective actions, verification, and record-keeping system related to allergen controls, please refer to Chapter 19 of the HACCP Guide, 4th Edition.
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,
(a) your firm’s HACCP plan for “Dung. Crabmeat, Scallops (Oxygen Restricted)” lists a critical limit (b)(4) at the receiving critical control point that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin. For products delivered under ice, FDA recommends that the product is completely surrounded by ice at the time of delivery.
(b) your firm’s HACCP plan for “Freezer vacuum pac, cooked, ready to eat, smoked fish” lists critical limits, (b)(4) at the brining critical control point, (b)(4) at the smoking/cooking critical control point, and (b)(4) at the cooling critical control point, that are not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin. At the brining critical control point, FDA recommends that you specify in your HACCP plan the maximum or minimum values for the critical factors of the brining or dry salting, and/or drying processes established by a scientific study. The critical factors are those that are necessary to ensure that the finished product does not have less than 3.5% water phase salt. The critical factors may include: brine strength or brine recipe for dry salting; brine to fish ratio; brining time; brining temperature; thickness, texture, fat content, quality, and species of fish; drying time; input/output air temperature, humidity, and velocity; and drier loading. At the smoking/cooking critical control point, FDA recommends that you specify the minimum or maximum value of the cook time and the internal fish temperature. We recommend that the internal temperature of the fish during hot smoking be maintained at or above 145°F throughout the fish for at least 30 minutes. We also recommend that you monitor continuously the internal temperature at the thickest portion of three of the largest fish in the smoking chamber with a continuous temperature-recording device (e.g, a recording thermometer) equipped with three temperature-sensing probes. In addition, we recommend visually checking the recorded data at least once per batch. At the cooling critical control point, you must specify the maximum cooler temperature in your HACCP plan. FDA recommends that the product is held at a cooler temperature of 40°F or below during the refrigerated storage of the finished product.
To establish the appropriate monitoring procedures, corrective actions, verification procedures, and record keeping system for the critical limits related to Clostridium botulinum toxin control, please refer to Chapter 13 of the HACCP Guide, 4th Edition.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6(c)(4). However,
(a) your firm’s HACCP plan for “Ahi, Blue Fin, Tombo, Albacore, Mahi, Ono” lists monitoring procedures and frequencies of (b)(4) by (b)(4) at the receiving critical control point and (b)(4) check of the (b)(4) at (b)(4) at the cooler storage critical control point that are not adequate to control histamine formation. For scombrotoxin-forming fish delivered refrigerated (not frozen) with a transit time of 4 hours or less, FDA recommends monitoring the date and time fish were removed from a controlled temperature environment before shipment and the date and time delivered, and the internal temperature of a representative number of fish at the time of delivery. For storage under ice, FDA recommends making visual observation of the adequacy of ice in a representative number of containers (e.g. cartons and totes) from throughout the cooler at sufficient frequency. To monitor the cooler temperature, FDA also recommends the use of continuous temperature recording device (e.g., a recording thermometer) with a visual check of the recorded data at least once per day.
(b) your firm’s HACCP plan for “Dung. Crabmeat, Scallops (Oxygen Restricted) lists a monitoring procedure and frequency, (b)(4) check of the (b)(4) at the cooler storage critical control point, that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin. For an adequate monitoring procedure and frequency, please refer to citation 3(a) above.
Please refer to Chapter 7 and Chapter 13 of the HACCP Guide, 4th Edition for additional information related to adequate monitoring procedures in controlling histamine and Clostridium botulinum toxin formation respectively.
4. 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 each of your three HACCP plans is not appropriate. Your corrective action does not ensure that adulterated product will not reach the consumer nor does it ensure that the root cause of the deviation is corrected.
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 (15) working days of 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 the revised HACCP plans, 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations
Please send your reply to the U. S. Food and Drug Administration, Attention: Lawton W. Lum, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have questions regarding any issues in this letter, please contact Compliance Officer Erlinda Figueroa at (510) 337-6795.
Barbara J. Cassens
San Francisco District