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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Onorato & Company, Inc. 10/25/11

  

Department of Health and Human Services' logoDepartment 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 CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Our Reference:  FEI 3001452589

October 25, 2011

David L. Pirotto, Chief Executive Officer
Onorato & Company, Inc.
P.O. Box 1144
South San Francisco, California 94080

WARNING LETTER

Dear Mr. Pirotto:

We inspected your seafood processing facility, located at 1332 San Mateo Avenue, South San Francisco, California on August 3, 4, 8, and 9, 2011. 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 chilled, histamine-forming fish, specifically Tuna, and refrigerated ready-to-eat canned Dungeness crabmeat 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.

Your significant violations were as follows:

1) 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,

a) Your firm’s HACCP plan for “Fresh Fish (histamine Producing Tombo, Escolar, Tuna, Ono, Yellowtail, Mahi-Mahi), whole fish, fillet/loins, whole dressed, headed and eviscerated, skin-on or skin-off fillets, and portions” lists a critical limit “(b)(4)” at the Receiving critical control point (CCP) that is not adequate to control histamine formation as a result of time/temperature abuse.  FDA recommends: (1) for fish delivered refrigerated (not frozen), all lots received are accompanied by transportation records that show that the fish was held at or below an ambient or internal temperature of 40°F throughout transit; or (2) for fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less, that time of transit does not exceed 4 hours AND the internal temperature of the fish at the time of delivery does not exceed 40°F; or (3) for fish delivered under ice, that the fish is completely surrounded by ice at the time of delivery; or (4) for fish delivered under ice on an open-bed truck, the fish is stored completely surrounded by ice AND the internal temperature of the fish at the time of deliver is 40°F; or (5) for fish delivered under chemical cooling media such as gel packs: there is an adequate quantity of cooling media that remain frozen to have maintained product at an internal temperature of 40°F or below throughout transit AND the internal temperature of the fish at the time of delivery is 40°F.  Please refer to the HACCP Guide, 4th Edition, for the appropriate monitoring procedures, corrective action, verification procedures, and record-keeping system that are applicable to critical limits established for your products.

b) Your firm’s HACCP plan for “Cooked Crab (various species), Crabmeat, Smoked products, Crayfish, Seafood salad and Shrimp” lists critical limits “(b)(4)” and “(b)(4)” at the Receiving CCP that is not adequate to control pathogen growth and toxin formation, specifically Clostridium botulinum toxin in reduced oxygen packaged fishery products, such as your refrigerated, unpasteurized Dungeness crabmeat.  FDA recommends: (1) for fish or fishery products, delivered refrigerated (not frozen), all lots received are accompanied by transportation records that show that the product was held at or below 40°F (below 38°F for the reduced oxygen packaged, unpasteurized Dungeness crabmeat); or (2) for products delivered under ice, that the product is completely surrounded by ice at the time of delivery; or (3) for products delivered under chemical cooling media, such as gel packs, that there is an adequate quantity of cooling media that remain frozen to have maintained product at or below 40°F (below 38°F for the reduced oxygen packaged, unpasteurized Dungeness crabmeat) throughout transit AND the internal temperature of the product at the time of the delivery is below 40°F (below 38°F for the reduced oxygen packaged, unpasteurized Dungeness crabmeat); or (4) for products delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less: the time of transit does not exceed 4 hours and the temperature of the product does not exceed 40°F (below 38°F for the reduced oxygen packaged, unpasteurized Dungeness crabmeat).

c) Your firm’s HACCP plan for “Cooked Crab (various species), Crabmeat, Smoked products, Crayfish, Seafood salad and Shrimp” lists a critical limit “(b)(4)” at the Cooler Storage CCP that is not adequate to control Clostridium botulinum toxin formation in your refrigerated reduced oxygen packaged, unpasteurized Dungeness crabmeat. FDA recommends that the cooler temperature be kept below 38°F.

2) You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4).  However,

a) Your firm’s HACCP plan for “Fresh Fish (histamine Producing Tombo, Escolar, Tuna, Ono, Yellowtail, Mahi-Mahi), whole fish, fillet/loins, whole dressed, headed and eviscerated, skin-on or skin-off fillets, and portions” lists a monitoring frequency “(b)(4)” at the Cooler Storage (Fresh) CCP that is not adequate to control histamine formation. Your firm’s HACCP plan for “Cooked Crab (various species), Crabmeat, Smoked products, Crayfish, Seafood salad and Shrimp” also lists the same monitoring frequency at the Cooler Storage CCP that is not adequate to control pathogen growth and toxin formation, specifically Clostridium botulinum toxin formation in refrigerated, reduced oxygen packaged, unpasteurized Dungeness crabmeat. FDA recommends monitoring of the cooler temperature by a continuous temperature data recorder, with visual check of the monitoring instrument at least once per day.

3) You must implement the monitoring procedures and frequencies that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4).  However, your firm has not been monitoring and documenting the temperature of your walk-in refrigerator where seafood is stored and/or processed. On August 3, 2011, when our investigator asked to see the cooler log for the walk-in refrigerator, you told him that your firm has not been monitoring and keeping record of the cooler storage temperature. Similar observation was noted in previous FDA inspections.
 
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).

a) However, your corrective action plans for “Fresh Fish (histamine Producing Tombo, Escolar, Tuna, Ono, Yellowtail, Mahi-Mahi), whole fish, fillet/loins, whole dressed, headed and eviscerated, skin-on or skin-off fillets, and portions” and “Cooked Crab (various species), Crabmeat, Smoked products, Crayfish, Seafood salad and Shrimp” at the Receiving CCP to control histamine formation and pathogen growth and toxin formation respectively, are not appropriate. Your corrective action does not correct the cause of the deviation, e.g., discontinue use of supplier or carrier until evidence is obtained that transportation practices have been improved.

5) You must monitor sanitation conditions and practices during processing with sufficient frequency, and maintain sanitation control records that, at a minimum, document monitoring and corrections, to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b) and (c). However, your firm is not monitoring and documenting sanitation conditions of the following areas of sanitation:

a) Safety of water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;

b) Condition and cleanliness of food contact surfaces;

c) Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments and from raw product to cooked product;

d) Maintenance of hand washing, hand sanitizing, and toilet facilities;

e) Protection of food, food packaging material, and food contact surfaces from adulteration;

f) Proper labeling, storage, and use of toxic compounds;

g) Control of employee health conditions; and

h) Exclusion of pests from the food plant.

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 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Please send your reply to the U. S. Food and Drug Administration, Attention: Darlene B. Almogela, 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.

Sincerely,

/s/

Barbara J. Cassens
District Director
San Francisco District