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WARNING LETTER

South Bay Cold Storage & Handling, Inc. MARCS-CMS 717080 —

Delivery Method:
VIA ELECTRONIC DELIVERY
Product:
Food & Beverages
Recipient:
Recipient Name
Jacob P. Bochove
Recipient Title
Owner/CEO
South Bay Cold Storage & Handling, Inc.

1351 Elwood Street
Los Angeles, CA 90021-2412
United States

JBochove@gmail.com
Issuing Office:
Human Foods Program

United States

January 22, 2026

WARNING LETTER

Re: CMS #717080

Dear Mr. Bochove:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 1351 Elwood Street, Los Angeles, CA 90021, from July 1, 2025, through July 8, 2025. During our inspection, the FDA investigator found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123.

Based on FDA’s inspectional findings, we have determined your scombroid species, vacuum-packed Dungeness crab and blue crabmeat and vacuum-packed smoked salmon products are 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)) in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Furthermore, 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 21 CFR 123.6 whenever a HACCP plan is necessary 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 Act, 21 U.S.C. § 342(a)(4). You may find the Act, the seafood HACCP regulation, and the June 2022 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA’s home page at www.fda.gov.

At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. You provided a response to the FDA-483 on July 23, 2025, including your revised undated HACCP Plan for “SCOMBROID,” revised undated HACCP Plan for “Dungeness Crab, Blue Crabmeat / Vacuum Packed products,” and revised undated HACCP Plan for “Salmon Smoked/ Vacuum Packed Products.” Your written response did not include any supporting HACCP documentation. After reviewing your response, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your response below.

Seafood HACCP Violations (21 CFR Part 123)

Your significant violations of the seafood HACCP regulation 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 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). Specifically, your firm does not have a HACCP plan to control the food safety hazard of undeclared allergens associated with your repackaging of different fish species. During our inspection, your firm was repackaging halibut without a HACCP plan.

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(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 revised HACCP plan for “Salmon Smoked/ Vacuum Packed Products” submitted with your July 23, 2025, response lists a critical limit in the plan for receiving refrigerated product that does not ensure the temperature of the product was held at or below an ambient or internal temperature of (b)(4)°F ((b)(4)°C) throughout transit. Your plan lists “(b)(4)” as the critical limit at the “(b)(4)” critical control point. Your response does not list the Clostridium botulinum hazard associated with receiving refrigerated vacuum-packed smoked salmon. Your firm should specify the Clostridium botulinum hazard at this receiving CCP.

b. Your revised HACCP plan for “SCOMBROID” submitted with your July 23, 2025, response lists a critical limit in the plan for receiving refrigerated product that does not ensure the temperature of the product was held at or below an ambient or internal temperature of (b)(4)°F ((b)(4)°C) throughout transit. Your plan lists “(b)(4)” as the critical limit at the “(b)(4)” critical control point. FDA recommends that refrigerated scombroid species be accompanied by transportation records showing the fish were held under 40°F throughout transit or the fish are received completely surrounded by ice.

c. Your revised HACCP plan for “Dungeness Crab, Blue Crabmeat / Vacuum Packed products” submitted with your July 23, 2025, response lists a critical limit in the plan for receiving refrigerated product that does not ensure the temperature of the product was held at or below an ambient or internal temperature of (b)(4)°F ((b)(4)°C) throughout transit. Your plan lists “(b)(4)” as the critical limit at the “(b)(4)” critical control point. It is important that processors ensure incoming seafood products were held at or below 40°F continuously during transit.

3. You must have a HACCP plan that, at a minimum, list monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). The monitoring procedure listed for the following HACCP plans are not adequate to control the hazards that are reasonably likely to occur:

a. Your revised HACCP plan for “Salmon Smoked/ Vacuum Packed Products” submitted with your July 23, 2025, response lists “(b)(4)” at the “(b)(4)” critical control point to monitor and control the Clostridium botulinum hazard associated with storing the vacuum-packed salmon received, stored and distributed by the firm. However, the plan does not list checking the data logger visually at least (b)(4) per day.

b. Your revised HACCP plan for “SCOMBROID” submitted with your July 23, 2025, response lists “(b)(4)” at the “(b)(4)” critical control point to monitor and control the Scombrotoxin (Histamine) hazard associated with the storage of yellowfin tuna, and anchovies observed in your coolers on July 1 to July 8, 2025. However, the plan does not list checking the data logger visually at least (b)(4) per day.

c. Your revised HACCP plan for “Dungeness Crab, Blue Crabmeat/Vacuum Packed products” submitted with your July 23, 2025, response lists “(b)(4)” at the “(b)(4)” critical control point to monitor and control the Clostridium botulinum hazard associated with storing the reduced oxygen packaging /vacuum packed Dungeness crabmeat and blue crabmeat distributed by your firm. However, the plan does not list checking the data logger visually at least (b)(4) per day.

4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, compliance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs) and maintain records of your observations as required by 21 CFR 123.11(b). However, you did not ensure all food contact surfaces, including utensils, were cleaned as necessary to protect against the food contamination as required by 21 CFR 117.35(d). This is related to the condition and cleanliness of food contact surfaces, as required by 21 CFR 123.11(b)(2).

Specifically, on July 1, 2025, your sanitation employee stated he does not use detergent to clean the shovels used to pick up ice. On July 1, 2025, inside of cooler #(b)(4), ice was observed in direct contact with mesh bags containing mussels, inside plastic bags directly in contact with live ready-to-eat oysters and added directly to fish on July 2, 2025.

The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your facility complies with all requirements of federal law, including applicable FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Please notify FDA in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documents. If you cannot complete all corrections within fifteen (15) days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Bruce E. Taylor, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740. If you have any questions regarding any issues in this letter, please contact Bruce E. Taylor via email at: Bruce.Taylor@fda.hhs.gov. Please include CMS reference #717080 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Thomas Kuntz
Acting Deputy Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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