- Yantai Shanhai Foodstuff Co., Ltd
- Issuing Office:
- Center for Food Safety and Applied Nutrition
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
FEB 13, 2015
VIA EXPRESS DELIVERY
Ji Yu Tang, General Manager
Yantai Shanhai Foodstuff Co., Ltd.
No. 6 Lande Road, Laishan District
Yantai, Shandong Province, China 264000
Reference # 447015
Dear Mr. Tang:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility Yantai Shanhai Foodstuff Co., Ltd. located at No.6 Lande Road, Laishan District, Shandong Province, Yantai, China on September 22-23, 2014. During that inspection, we found that you had violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm.
We acknowledge receipt of your response sent via email on October 15, 2014. Your response included a description of your corrective measures, copies of your revised HACCP plans for your frozen mackerel fillet/piece, frozen, breaded fish fillet/piece and frozen crab flesh, as well some photographs. We note that your firm did not provide a revised HACCP plan for your frozen, vinegar-soaked mackerel pieces. We have evaluated the documentation and found that you have continuing serious deviations from the seafood HACCP regulation, as further explained in this letter.
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 frozen, vinegar-soaked mackerel pieces, frozen crab flesh, and frozen mackerel fillet/piece products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm.
Your significant deviations are as follows:
1. 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 CPR 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 plans do not list critical control points as described below:
a. The HACCP plan for frozen, vinegar-soaked mackerel pieces that was collected during the inspection does not list a critical control point for processing to control the identified hazard of scombrotoxin (histamine) formation. Specifically, our investigator observed that the fish (b)(4). Consequently, your firm needs to ensure that the fish are not exposed to time and temperature abuse conducive to scombrotoxin (histamine) formation during this extended soaking period.
b. The revised HACCP plans for frozen mackerel fillet/piece and frozen crab flesh submitted with your October 15, 2014, response and your HACCP plan for your frozen, vinegar-soaked mackerel pieces that was collected during the inspection do not list critical control points for
i. (b)(4) - specifically, our investigator observed during the inspection that prior to processing, the fish are placed in a (b)(4). Thawing, when conducted for an (b)(4) period, needs to be included as a critical control point to control scombrotoxin (histamine) formation in your raw material mackerel and pathogen growth in your raw material crab meat.
ii. (b)(4) - specifically our investigator observed during the inspection that your firm conducts a non-refrigerated (b)(4). Our investigator observed that this (b)(4) was conducted at temperatures between (b)(4) with an exposure time as (b)(4), before final freezing. This (b)(4) should be included as part of the cumulative exposure times at unrefrigerated conditions to control scombrotoxin (histamine) formation in your HACCP plan for frozen, vinegar-soaked mackerel pieces, your HACCP plan for HACCP plan for frozen mackerel fillet/piece and your HACCP plan for your frozen crab flesh to control pathogen growth.
c. The revised HACCP plan for your frozen crab flesh does not list a processing critical control point. Our investigator observed that your crab product undergoes significant handling after thawing under unrefrigerated conditions. Significant handling under unrefrigerated conditions poses a risk for pathogen growth including Staphylococcus aureus growth and toxin formation.
2. You must have a HACCP plan that, at a minimum, lists the critical limits, 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 revised HACCP plan provided with your October 15, 2014, response for your frozen crab flesh lists a critical limit of "less than 30 ppm sulfiting agents in the sample" at the raw materials receiving critical control point. This critical limit is not adequate to control the hazard of undeclared sulfites. Because your firm is receiving sulfite-treated crab (i.e., at levels greater than 10 ppm) your firm must ensure that the sulfites are declared on the labels of each individual package. FDA recommends conducting a visual check of each batch of labels to ensure that the sulfites are properly declared.
3. Because you chose to include a corrective action plan in your revised HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However your corrective actions listed in your revised plans are inadequate, as described below:
a. Your revised HACCP plan for frozen mackerel fillet/pieces does not address:
i. disposition of the product when there is a need to take a corrective action (e.g., adding ice or returning to the cooler) at the processing critical control point; or
ii. identifying the source of the metal and fixing the equipment at the metal critical control point.
b. Your revised HACCP plan for frozen, breaded fish fillet/pieces does not address correcting the cause of the critical limit deviation at the batter critical control point.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan(s), five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan(s), and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
Additionally, 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 re-inspection-related costs. A re-inspection is 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of there-inspection and assessing and collecting there-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection- related costs from the U.S. Agent for the foreign 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 re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Purnell via email at email@example.com.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition