Inspections, Compliance, Enforcement, and Criminal Investigations
HPC Foods, Ltd. 6/27/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
VIA UNITED PARCEL SERVICE
Our Reference: FEI Nos. 2923364 and 3004329638
June 27, 2012
Craig P. Tottori, President
HPC Foods, Ltd.
268 Libby Street
Honolulu, Hawaii 96817
Dear Mr. Tottori:
We inspected your seafood processing facilities, HPC Foods, Ltd, Produce Processing Center, located at 1308 Hart Street, Honolulu, Hawaii, and Central Distribution Center located at 274 Libby Street, Honolulu, Hawaii, on March 19, 20, 21, and 23, 2012. 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, ready-to-eat, raw Lomi 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.
We acknowledge receipt of your Operations Manager's April 6, 2012 letter and attachments, in response to the FDA 483 List of Observations. The response to the current inspection does not adequately address all the deviations observed. The deviations listed in this letter are based on the inspection and our review of your response letter.
Your significant violations 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical' property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for "Lomi Salmon" did not list the food safety hazard of Allergens.
We acknowledge that your firm considered Allergens in your Hazard Analysis Worksheet as a potential hazard likely to occur and you are controlling it through your (b)(4). However, FDA has identified finfish as a major allergen and as a food safety hazard, it must be included in your HACCP plan.
2. 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 CFR 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 "Lomi Processing" does not list the critical control point of:
Thawing, to control the food safety hazard of pathogen growth, including the potential for Clostridium botulinum growth and toxin formation. During the inspection, the FDA investigator observed your firm thawing the raw salmon in their vacuum sealed packages in your (b)(4). The investigator observed the total thawing time was about (b)(4). This situation creates an anaerobic environment conducive to Clostridium botulinum toxin formation. FDA recommends that temperatures continuously be maintained at or below 38°F during thawing of the sealed packages of salted salmon.
To address this Thawing issue, your Operations Manager stated in his April 6, 2012 response that (b)(4) .
We acknowledge the reference to Table A-2 in Appendix 4 of the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Guide). However, acceptable exposure times vary with exposure temperatures. During the inspection, the FDA investigator observed that your (b)(4). In the absence of temperature controls, Clostridium botulinum growth and toxin formation is likely to occur in the sealed vacuum packages (i.e. due to the potential for an anaerobic environment over time). Therefore, a critical control point must be in place at this step to control the thawing temperatures. The values in Table A-2 may be used as guidance for taking a corrective action when the critical limit of 38°F is exceeded.
3. 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 plans for "Lomi (raw/finished)" and "Lomi Processing" list a critical limit (b)(4) at the Refrigerated Storage critical control points that is not adequate to control pathogen growth and toxin formation. FDA recommends that the product is held at a cooler temperature of 40°F or below. Critical limits during the refrigerated storage that specify a cumulative time and temperature of exposure are not ordinarily suitable to control the hazard because of the difficulty in tracking the specific product and the specific cumulative temperature exposures that the product experiences.
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). However, your corrective action plan for “Lomi (raw/finished)” and “Lomi Processing” at the “Refrigerated Storage” critical control point to control pathogen growth and toxin formation is not appropriate. Your corrective action (b)(4) is not adequate to ensure that the cause of the critical limit deviation is corrected. FDA recommends that in addition to replacing your (b)(4) if it is functioning erratically, you also make repairs or adjustments to the malfunctioning cooler.
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 copies of the revised HACCP plans, 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 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: Lawton W. Lum, 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.
Barbara J. Cassens
San Francisco District