Inspections, Compliance, Enforcement, and Criminal Investigations
Ham Produce and Seafood, Inc. 05-Jul-07
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
Our Reference: FEI 3004971975
July 5, 2007
May Hugh, President
Ham Produce and Seafood, Inc.
918 Bannister Street
Honolulu, Hawaii 96819
Dear Ms. Hugh:
We inspected your seafood processing facility, located at 748 Puuhale Road, Honolulu, Hawaii, on March 26, 27, 28, and April 2, 2007. 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 and 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 histamine forming fish including [redacted] 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 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 "Fresh Fish, dressed, loined, steaked (histamine forming fish including [redacted] etc.)" lists a monitoring procedure and frequency at the Raw Material Storage and at the Finished Product Storage critical control points, that are not adequate to control histamine forination. Your HACCP plan lists "Product completely covered in ice throughout storage (to ensure that product is not exposed to temperatures above [redacted]F for more than [redacted], hours cumulatively during raw material and finished product storage and butchering/packaging)" at the "Raw material storage" and "Finished product storage" critical control points (CCP). However, your firm no longer stores product on ice. Consequently, you need to amend your HACCP plan to accurately reflect your monitoring procedure; i.e., stored under refrigeration. Please be advised that when products are stored under refrigerated conditions, we recommend a method of continuous monitoring & recording storage temperature, i.e., a 24-hour continuous monitoring device and/or high temperature alarm.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure of taking the "internal temperature of fish" on "10% of every delivery" at the Receiving critical control point listed in your HACCP plan for "Fresh Fish, dressed, loined, steaked (histamine forming fish including [redacted], etc.)." Specifically, your receiving record for March 23, 2007 indicates that more than [redacted] pounds of histamine forming fish were received; yet no temperatures were recorded. Furthermore, on March 26, 2007, your firm received about [redacted] pounds of fresh [redacted] and [redacted] from [redacted], which were not included in your receiving records. Mr. Rogelio P. Lamug, Fish Department Manager, told the FDA investigator that your firm does not routinely take temperatures of fish received from other vendors other than the [redacted].
3. 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 "Fresh Fish, dressed, loined, steaked (histamine forming fish including [redacted] etc.)" at the Receiving critical control point to control histamine formation is not appropriate.
a) Although sensory evaluation is acceptable for assessing the quality of the fish, it is not adequate to ensure the safety of the affected product.
b) The corrective actions listed in 1 (b) and 1(c) at the receiving CCP can not be accomplished based on your monitoring procedures at this same CCP. There is no means for you to determine the cumulative time that the product temperature was above [redacted]F based on your procedures that include only monitoring the internal temperature of the fish at receipt. Appropriate corrective actions may include rejecting an lot of fish that is received with an internal temperature above the [redacted]F temperature critical limit that is listed in your plan; or alternatively performing histamine testing on a representative number of fish in the lot and rejecting the lot if the histamine levels are greater than or equal to 50 parts per million.
4. You must fully document in your records all corrective actions taken, to comply with 21 CFR 123.7(d). However, you did not document that a corrective action was taken when you deviated from your critical limit of "Internal temperature of fish not to exceed 40 F" for [redacted] and [redacted] at the "Receiving" critical control point to control histamine.
5. You must conduct a hazard analysis 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 critical control points, to comply with 21 CPR 123.6 (a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for "Fresh Fish, dressed, loined, steaked (histamine forming fish including [redacted], [redacted], [redacted], etc.)" does not list the critical control point of "Receiving" at the auction house for controlling the food safety hazard of histamine formation.
While we acknowledge that you have initiated corrective measures to address the observations noted on the Form FDA 483, further actions will be necessary to bring your firm into full compliance.
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) 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: Ms. Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have any questions regarding any issue in this letter, please contact Ms. Figueroa at (510)337-6795.
Barbara J. Cassens
San Francisco District
cc: Sam Hugh, Vice-President