Public Health Service Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
March 4, 2016
Via UPS Overnight Delivery
Return Receipt Requested
Kevin K. Lau
Dodwell Co., Inc.
435 4th Street
Oakland, CA 945607
Dear Mr. Lau:
We inspected your seafood processing facility, located at 435 4th Street, Oakland, CA 94607 on November 27 through December 2, 2015. 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 Live/Fresh Shellfish, and your 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:
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, your firm’s HACCP plan for Live/Fresh Shellfish lists a critical limit (s), of “Cooler (b)(4)°F”, at the “Receiving” and “Storage” critical control points that is not adequate to control pathogen growth. FDA recommends that products be held at or below an ambient or internal temperature of 40°F throughout transit, or products be completely surrounded by ice at the time of delivery. FDA also recommends that products be held at or below an ambient or internal temperature of 40°F during cooler storage or that the products be completely and continuously surrounded by ice throughout the storage time.
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, your firm’s HACCP plan for Live/Fresh Shellfish lists a monitoring frequency at the “Storage” critical control point that is not adequate to control pathogen growth. Cooler air temperature should be monitored with a continuous recording device, and a visual check of the recorded data at least once per day.
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 actions plan for Live/Fresh Shellfish] at the “Receiving” critical control point to control pathogen growth is not appropriate. Your corrective action must ensure that the cause of the deviation is corrected. At receiving, one way to ensure the cause of the deviation is corrected may involve discontinuing the supplier or carrier until evidence is obtained that the identified transportation handling practices have been improved.
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 maintenance of hand washing, hand sanitizing, and toilet facilities and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by: a layer of removable black stains and a rust color stain from the overflow hole to the drain hole of your hand washing sink, and two dead mice on a glue board inside your non-functional coolers used to store rejectamenta.
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 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.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Your written response should be sent to Lawton W. Lum, Director of Compliance, at the address noted above and should reference unique identifier 491381. If you have any questions concerning this letter, please contact Compliance Officer Sergio Chavez at (510) 337-6886.