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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Southwest Traders, Inc. 10/25/11

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

October 25, 2011

Ref: 2012-DAL-WL-3

WARNING LETTER

CERTIFlED MAIL
RETURN RECEIPT REQUESTED

Ken Smith, CEO
Southwest Traders, Inc
27565 Diaz Road
Temecula, California 92590
 

Dear Mr. Smith

We inspected your seafood processing facility located at 8900 Old Hickory Trail, Dallas, Texas 75237 on August 1-4, 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 CFR 123). 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 tuna fish salad is adulterated in that it has been prepared, packaged, 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 Product Hazards & Controls Guidance through links in FDA's home page at www.fda.gov

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 critical control points, 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 your firm's refrigerated tuna fish salad entilled "Seafood (fresh)" does not list the potential species related hazard of scombrotoxin (histamine) as a food safety hazard that is reasonably likely to occur in the refrigerated tuna fish salad product received, stored, and distributed by your firm (FDA-483 Item 5)

We acknowledge receipt of your response received on August 22, 2011, which states scombrotoxin (histamine) has been added as a hazard to your "Seafood (fresh)" HACCP plan.  However, you failed to provide documentation of the revised HACCP plan for our evaluation of your corrective action

2.    You must conduct a hazard analysis to determine whether there are food safely hazards that are reasonable 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 of result, be prevented, eliminated, or reduced to acceptable levels. However, your firm's "Seafood (fresh)" HACCP plan does not list receiving as a critical control point for your refrigerated tuna fish salad (FDA-483 Item 3).

We acknowledge your firm's response which states you have now added receiving as a critical control point. However, your response is inadequate because you failed to submit documentation to support the corrective action.

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(d)(4). However, your firm's HACCP plan for "Seafood (fresh)" lists a monitoring frequency at the Critical Control Point (CCP) 1B, Product Storage Refrigeration that is not adequate to control scombrotoxin (histamine). Your firm does not have immediate access to continuous temperature monitoring data of your cooler maintained by an outside company.

Your response to FDA-483 Item 1 stated that the cooler thermometer probe was found to be defective and a new probe has been placed on order. Your firm's response does not address how you will obtain immediate access to continuous temperature monitoring data maintained by the outside company.

4.    You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4).  However, your firm did not follow the monitoring procedure or frequency of checking the cooler temperature each work day with a calibrated thermometer at Critical Control Point (CCP) 1B. Product Storage Refrigeration to control scombrotoxin (histamine) as listed in your "Seafood (fresh)" HACCP plan for refrigerated tuna fish salad (FDA-483 Item 1).

Your HACCP plan "Seafood (Fresh)" which covers your firm's refrigerated tuna fish salad has a monitoring requirement at Critical Conlrol Point (CCP) 1B, Product Storage Refrigeration that states the Supervisor or warehouse personnel are required to check and document the cooler temperature each work day with a calibrated thermometer.

During the inspection, the Investrgator requested documentatron that demonstrates compliance with the CCP and was informed that because your firm has continuous monitoring of your firm's cooler by an outside company, your firm had not been monitoring and documenting cooler temperatures since approximately November 2010, and you depended on the alarm monitoring company to notify you of any cooler temperature deviations.

Your HACCP plan "Seafood (Fresh)" which covers your firm's refrigerated tuna fish salad has a monitoring requirement at Critical Control Point (CCP) 1B, Product Storage Refrigeration that states the Supervisor or warehouse personnel are required to check and document the cooler temperature each work day with a calibrated thermometer.

During the inspection, the Investrgator requested documentatron that demonstrates compliance with the CCP and was informed that because your firm has continuous monitoring of your firm's cooler by an outside company, your firm has not been monitoring and documenting cooler temperatures since approximately November 2010, and you depended on the alarm monitoring company to notrfy you of any cooler temperature deviations.

Your response to FDA-483 Item 1 stated that the cooler thermometer probe was found to be defective and a new probe has been placed on order and cooler and freezer temperature logs are being monitored, checked with a calibrated thermometer and documentation maintarned.  However, you failed to submit documentation to support the corrective actions 

5. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a).  Your firm did not take a corrective action to control the formation of scombrotoxin (histamine) when your process for refrigerated tuna fish salad deviated from your critical limit at the Critical Control Point (CCP) 1B, Product Storage Refrigeration (FDA-483 Item 1). CCP 1B when temperatures reach (b)(4) degrees Fahrenheit for more than (b)(4), your correctrve action for CCP-1B calls for immediate
notification to the company.

During the inspection, a random review of refrigeration temperature records maintained by the outside company revealed that your firm had to request the temperature data from the alarm company and that temperature readings were above (b)(4) degrees Fahrenheit for more than (b)(4) 100% of the time. The readings provided covered the dates of 7/11/2011 - 8/2/2011 Your firm was unaware of this temperature deviation and no corrective action was taken.

Your firm's response states that the readings were due to a defective thermometer probein the cooler and a new probe is on order and will be installed when received and that your firm checking cooler and freezer temperatures at (b)(4) and is reviewing refrigeration and calibration records on a (b)(4) basis. However, your response is inadequate because you failed to provide a corrective action plan regarding the out-of-temperature readings or copies of records now being maintained to demonstrate adequate corrective action.

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 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.

Please send your reply to the Food and Drug Administration, Attention: Elvia Cervantes, Compliance Officer, 4040 N. Central Expressway, Suite 300, Dallas. Texas 75204. If you have any questions regarding any issues in this letter, please contact Ms. Cervantes at (214-253-5236).
 

Sincerely,
/S/
Reynaldo R Rodrigueg, Jr.
District Director
Dallas District
 

cc:

Duane L Gilbert, Vice President of Operations
Southwest Traders Inc.
8900 Old Hickory Trail
Dallas, Texas 75237