- Blue Ocean of Colorado, Inc.
- Issuing Office:
- Denver District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
January 27, 2016
UPS via Overnight
Ellen Y. Kim, Owner
Blue Ocean of Colorado, Inc.
3870 Paris Street, Unit 2
Denver, CO 80239
Dear Mrs. Kim:
We inspected your firm, Blue Ocean of Colorado, Inc. located at 3870 Paris Street, Unit 2, Denver, Colorado on November 6 and 12, 2015. Our inspection found that your firm has serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). In accordance with 21 CFR §123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the fishery products processed there 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 vacuum packaged Yellowtail amberjack, Bigeye and Yellowfin tuna, salmon, and fresh fluke, are all adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act, the Seafood HACCP Regulation, and FDA’s Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition, April 2011 (the Hazard Guide) through links in FDA’s home page at www.fda.gov.
The deviations that were found during the inspection were 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 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 plans for yellowtail, tuna, mackerel, and Aji do not list the critical control point of allergens for controlling the food safety hazard of fish allergens. Specifically, your firm packs/re-packs fish including tuna and does not label the packages of the fish with the specific name of the fish. Although your firm’s fish is a single ingredient, undeclared allergens such as fish must be identified on the label with the specific name of the fish, e.g. tuna, salmon.
2. 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 yellowtail lists a critical limit of (b)(4) (Fahrenheit) at (b)(4) critical control point that is not adequate to control the food safety hazard of Clostridium botulinum toxin formation. Specifically, your HACCP plan lists the product to be (b)(4) instead of the temperature of 38°F that will control the food safety hazard of Clostridium botulinum toxin formation. In addition, you do not document or record the presence of (b)(4) the yellowtail.
3. You must implement the monitoring procedures and frequency that you have listed in the HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure and frequency of “Receipt of TTI and product” at the (b)(4) critical control point (CCP) to control Clostridium botulinum toxin formation listed in your HACCP plan for vacuum packaged yellowtail. Specifically, you do not have any documentation that the time, temperature indicators (TTI’s) and (b)(4) were checked on the received shipments of (b)(4) yellowtail between 01/01/2015 and 11/12/2015. The (b)(4) yellowtail is consumed raw and/or cooked by the consumer.
In addition, your firm did not follow the monitoring procedure or frequency of checking the (b)(4) of fish and/or ice at the (b)(4) CCP to control the formation of scombrotoxin (histamine) listed in your HACCP plan for tuna, mackerel, and Aji.
Furthermore, your firm did not follow the monitoring procedure of finished product storage and histamine at the (b)(4) critical control point to control Clostridium botulinum toxin and histamine formation listed in your HACCP plan for yellowtail and histamine in your HACCP plan for tuna, mackerel, and Aji.
4. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the (b)(4) critical control point to control Clostridium botulinum toxin listed in your HAACP plan for yellowtail and at the (b)(4) CCP to control the formation of scombrotoxin (histamine) listed in your HACCP plan for tuna, mackerel, and Aji.
We may take further action if you do not promptly correct these violations. For instance, we may initiate regulatory action without further informal notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct these deviations. You should include in your response documentation such as your HACCP plans, copies of all related monitoring records and corrective actions, labeling, or other useful information that would assist us in evaluating your compliance. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
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 re-inspection 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.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at 303-326-3024.
LaTonya M. Mitchell
Denver District Director
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