| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human Services
VIA UNITED PARCEL SERVICE
Our Reference: FEI3004747039
November 19, 2010
Eriko Fujino, President
Fujino Enterprises, Inc.
Dba Blue Ocean Smokehouse
P.O. Box 370594
Montara, California 94037
WARNING LETTER
Dear Ms. Fujino:
We inspected your seafood processing facility, located at 205 Yale Avenue, Princeton-By-The Sea, California, on July 28,29, and August 3, 2010. 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 refrigerated, vacuum packaged, ready-to-eat hot smoked and cold smoked salmon is adulterated, in that it has 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 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, your firm's HACCP plans for "HOT SMOKED SALMON" and "COLD SMOKED SALMON" list critical limits at the Brining critical control point that are not adequate to control pathogen growth and toxin formation. Your HACCP plans indicate that brining"is to occur for a (b)(4) Because certain pathogenic organisms, such as Staphylococcus aureus, are salt tolerant, FDA recommends that brining be conducted under refrigerated conditions (i.e., 40°F or below) and that you list brining temperature as a critical limit in your HACCP plans.
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).
a. However, your firm's HACCP plans for "HOT SMOKED SALMON" and "COLD SMOKED SALMON" list a monitoring frequency (b)(4) at the Refrigerator Storage critical control point that is not adequate to control pathogen growth and Clostridium botulinum toxin formation. 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.
b. However, your firm's HACCP plans for "COLD SMOKED SALMON" lists a monitoring frequency of (b)(4) at the Smoking critical control point that is not adequate to control pathogen growth and Clostridium botulinum toxin formation. FDA recommends continuous monitoring of every batch, by the instrument itself, with visual check of the monitoring instrument at least once per batch.
c. However, your firm's HACCP "HOT SMOKED SALMON" lists a monitoring frequency of (b)(4) at the Smoking critical control point that is not adequate to control pathogen growth and Clostridium botulinum toxin formation. In addition to continuous monitoring, FDA recommends a visual check of the monitoring instrument at least once per batch.
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).
a. However, your firm did not follow the monitoring procedure of (b)(4) of (b)(4) at the Receiving critical control point to control "Pathogen growth" listed in your HACCP plan for "COLD SMOKED SALMON." Specifically, on July 22, 2010, you received (b)(4) Salmon but internal temperatures were not taken on any of the fish.
b. However our firm did not follow the monitoring procedures of (b)(4) at the Brining critical control point to control "Pathogen growth, C. Botulism" listed in your HACCP plan for "HOT SMOKED SALMON." Further your firm also did not follow the monitoring procedure of (b)(4) the (b)(4) of finished product listed in your HACCP plan for "HOT SMOKED SALMON." On July 29, 2010, our investigator observed that your employees made the brining solution. However, no measurements were taken of the brine strength, brining time specifically the end time, brine to fish ratio, and fish thickness. The percent water phase salt is not being tested on every batch of finished product as well.
c. However, your firm did not follow the monitoring procedure of (b)(4) at the Smoking critical control point to control "Pathogen growth, parasites, C. Botulism" listed in your HACCP plan for "HOT SMOKED SALMON." Specifically, on July 29, 2010, our investigator observed that only (b)(4) was used in the smoker (b)(4). In addition, your smoker for "Hot Smoke Sockeye," and "Hot Smoke King Salmon" dated July 24, 29, and 30, 2010, show that only (b)(4) for each production date was monitored at the smoking critical control point.
4. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the Brining, Smoking and Cooler Storage critical control points to control pathogens and C. botulinum toxin formation listed in your HACCP plans for "COLD SMOKED SALMON" and "HOT SMOKED SALMON." For example, in July 2010, your firm acknowledged receiving (b)(4) pounds of frozen salmon in which (b)(4) of it was processed for ready-to-eat, refrigerated, hot and cold smoked salmon. Based on record review and discussion during the inspection, you did not monitor and maintain records such as receiving logs, salinity measurements, internal cook temperatures, or have records for other critical factors.
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).
a. However, your corrective action plan for "COLD SMOKED SALMON" at the Receiving critical control point (b)(4) to control pathogen growth is 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 changed.
b. However, your corrective action plans for "COLD SMOKED SALMON" and "HOT SMOKED SALMON" at the Smoking and Refrigerator Storage critical control point are not appropriate. Your corrective actions do not correct the cause of the deviation, e.g., make repairs or adjustments to the smoking chamber and the malfunctioning cooler.
6. 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 with sufficient frequency, the following areas of sanitation:
a. Safety of Water. On July 28, 2010, our investigator observed that your firm's water reservoir for your ice machine is corroded and contained a greenish, slimy substance. In addition, on July 29, 2010, our investigator observed that there is no back flow prevention device on a faucet used to attach a hose that is used in the production area.
b. Prevention of cross-contamination. On July 29, 2010, our investigator observed that plastic bins used to store fish and fishery products were cleaned on the floor of the production area. Our investigator also observed that the thermometer probe used to monitor the internal temperature in the smoker was not cleaned before and after its use. In addition, on the same day, our investigator observed that a hose used in the production area is stored on the floor. Employees picked up the hose to rinse off and/or remove ice from salmon fillets and immediately returned to handling the salmon without changing gloves or washing hands.
7. 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
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.
These records are required for the processing of vacuum packed, ready-to-eat cold smoked and hot smoked salmon.
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 in violation of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] and the seafood HACCP regulation. We may also take further action to enjoin your firm from operating in violation of Section 415 of the Act (21 U.S.C. § 350d) and 21 CFR Part 1, Subpart H.
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.
Please be advised that FDA noted a product label for Black Cod. Black Cod is not an acceptable market name for fish in the US. An acceptable market name for the species Anoplopoma fimbria, the fish you currently identify as Black Cod is "sablefish."
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), and is registered in accordance with the Food Facility Registration regulation (21 CFR Part 1, Subpart H). 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: Ms. Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have questions regarding any issues in this letter, please contact Ms. Figueroa at (510) 337-6795.
Sincerely,
/S/
Barbara J. Cassens
District Director
San Francisco District
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