- Seorak Clean Food
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
JAN 27, 2014
VIA EXPRESS DELIVERY
Mr. Hae Jun Kim
Seorak Clean Food
950 Nohak-dong, Sokcho
Republic of Korea (South)
Reference No. 418335
Dear Mr. Kim:
We inspected your seafood processing facility, Seorak Clean Food, located at 950 Nohak-dong, Sokcho, Republic of Korea, on September 9-10, 2013. During that inspection, we found that you had serious 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, FDA issued a FDA-483, Inspectional Observations, listing the observations found at your firm.
We acknowledge receipt of your response sent via fax on November 20, 2013. Your response included descriptions of your corrective measures, a HACCP plan for your squid sausage, and completed monitoring records. We have assessed the response and have continuing concerns, as further described in this letter.
In accordance with 21 CFR 123.6(g), failure of a processor of fish and 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 squid sausage is adulterated, in that it has been prepared, packed, or held under conditions whereby it may have been rendered injurious to health.
Further, our review of labels collected during the inspection finds that your cuttlefish sundae product is misbranded within the meaning of Section 403(a)(1) of the Act, in that the label is false or misleading, as described further below.
Your significant deviations 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 (b)(4) provided with your November 20 response does not list the food safety hazards of undeclared allergens and pathogens, including Clostridium botulinum and Bacillus cereus growth and toxin formation.
a. Your product includes soy sauce as an ingredient and soy is one of the eight major allergens. Your HACCP plan should include controls to ensure that the allergens are appropriately declared on each finished product label. We suggest including a critical control point in your HACCP plan to monitor each batch of labels for declaration of all allergenic ingredients.
b. Our investigator noted during the inspection that your (b)(4). Packaging conditions that reduce the amount of oxygen in the package, such as vacuum packaging, increase the potential for Clostridium botulinum growth and toxin formulation. FDA recommends as a control for Clostridium botulinum in frozen vacuum-packaged products that firms include on the label of each package, statements such as “Keep Frozen,” and “Important, keep frozen until used, thaw under refrigeration immediately before use.” We further recommend monitoring each batch of labels for the statements.
c. (b)(4) is an ingredient of your product which poses a risk for Bacillus cereus growth and toxin formation if subjected to time and temperature abuse during handling. Your HACCP plan should include controls for cooling the (b)(4) or for controlling time/temperature abuse after the (b)(4) is cooked to prevent growth and toxin formation, specifically from Bacillus cereus.
2. You must have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(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 (b)(4) provided with your November 20 response does not list a critical control point for (b)(4).
Your plan lists that the product will be (b)(4). However, this does not ensure that the exposed products are cooled to a final temperature adequate to control pathogen growth within an adequate corresponding time limit. FDA recommends cooling cooked products to 70°F within 2 hours, and further cooling to 40°F within an additional 4 hours to ensure product safety.
3. 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 (b)(4) included in your November 20 response is not adequate.
Your firm’s HACCP plan for (b)(4) lists a “(b)(4).” However, your plan lists a critical limit for the cook time as (b)(4). Consequently, (b)(4). In addition, there is no assurance that the product (b)(4) is maintained during the entire (b)(4). Further, there is no indication as to whether your firm is (b)(4) of the cooking apparatus.
4. 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). During the inspection, our investigator noted that you are not complying monitoring to ensure compliance with the eight key areas of sanitation. Our review of the documents provided with your response revealed that your firm continues to fail to ensure that key areas of sanitation, including condition and cleanliness of food contact surfaces, the safety of water, prevention of cross-contamination, employee health, and prevention of adulteration of food and food contact surfaces, are monitored on a routine (daily) basis.
Your (b)(4) product is misbranded within the meaning of Section 403(a)(1) of the Act (21 U.S.C. § 343(a)(1)) in that the label is false and misleading. Your product is labeled as “(b)(4)”; however, the product is manufactured from (b)(4).
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 or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans, 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 applicable laws and regulations. Submission of the information in English will assist in our review. 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 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
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.
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 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-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.
Please send your reply to Food and Drug Administration, Attention: Standra Purnell, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 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
Charlotte A. Christin
Office of Compliance
Center for Food Safety
and Applied Nutrition