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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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S W Seafood, Inc. 1/11/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433 

January 11, 2012
 

WARNING LETTER NYK-2012-10

VIA UNITED PARCEL SERVICE
 

Ms. Hau Nguyen, President/Owner
S W Seafood, Inc.
474 - 476 Baltic Street
Brooklyn, NY 11217-2508
 

Dear Ms. Nguyen:

We inspected your seafood processing facility, located at 474 - 476 Baltic Street; Brooklyn, NY 11217-2508 on December 5, 2011 through December 12, 2011. 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 (21 C.F.R. 123). In accordance with 21 C.F.R. 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 live aquacultured Barramundi, Striped Bass, Tilapia, and live wild caught Buffalo Fish 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 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 you must have, and implement, a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 C.F.R. 123.6 (a) and (b).
 

•  Your firm does not have a HACCP plan(s) for your live aquacultured Barramundi, Striped Bass, Tilapia, and live wild caught Buffalo Fish to control the food safety hazard(s) of aquaculture drugs and/or environmental chemicals. Please be advised that in accordance with 21 C.F.R. 123.6(b)(2) firms may group kinds offish and fishery products together if the food safety hazards, critical control points, critical limits, and procedures requires to be identified and performed are identical.

Chapter 9 and 11 of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition can provide guidance in determining the appropriate controls for your process.

Once you have conducted a hazard analysis for your seafood products, your HACCP plan must, at a minimum, list hazards that are reasonably likely to occur, and include appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc., to ensure that the food safety hazards are controlled to comply with 21 C.F.R. 123.6(c).

2. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 C.F.R. 123.11 (b), to comply with 21 C.F.R. 123.11 (c). However, your firm did not maintain sanitation monitoring records and sanitation correction records for safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions, and exclusion of pests.

3. No one associated with your firm has completed HACCP training or is HACCP qualified through job experience, as required by 21 C.F.R. 123.10.

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 from your 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 C.F.R. Part 123) and the Current Good Manufacturing Practice regulation (21 C.F.R. Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Your response should be sent the Food and Drug Administration; Attention:
 

LCDR Frank Vemi
Compliance Officer
U. S. Food and Drug Administration
158-15 Liberty Avenue, Room 4050
Jamaica, NY 11433

If you have any questions about the content of this letter please contact: LCDR Vemi at (718) 662-5702.
 

Sincerely,

/S/
Ronald M. Pace
District Director
New York District
 

cc:

Mr. Wai K. Chui, Manager
S W Seafood, Inc.
474 - 476 Baltic Street
Brooklyn, NY 11217 -2508