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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Marine Foods Express, LTD 11/1/12

  

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

November 1, 2012

2013-DAL-WL-009

WARNING LETTER


UPS OVERNIGHT

Jason Poon, Chief Executive Officer
Marine Foods Express, LTD
5757 South Loop E
Houston, TX  77033-1604

Dear Mr. Poon:

We inspected your seafood processing and importer establishment, located at 5757 South Loop E, Houston, Texas, on August 14 through 16, 2012. 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 Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).  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).  

As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12.  In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123.  If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4). 

Accordingly, your refrigerated pasteurized crabmeat products, imported frozen tilapia, and imported frozen cooked whole crawfish with Cajun flavor, 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 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 refrigerated pasteurized crabmeat does not list the food safety hazard of Clostridium botulinum.

We acknowledge receipt of a response to the FDA 483 that your representative sent by email on September 6, 2012. However, your response does not propose a correction to this observation, and you have not provided an updated HACCP plan for our evaluation.

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 (CCP) to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for refrigerated pasteurized crabmeat lists a critical limit at the receiving critical control point that is not adequate to control the hazard of pathogen growth and toxin formation, including C. botulinum.

Specifically, your plan lists a critical limit of “product must not be above (b)(4) deg upon receipt”. This critical limit does not ensure that refrigerated fishery products have been held at or below an ambient or internal temperature of 40°F throughout transit.

The September 6, 2012, response states that you have created a new log to record (b)(4) data, but you have not provided an updated HACCP plan for our review and we are therefore unable to evaluate the adequacy of this 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(c)(4).  However, your firm’s HACCP plan for refrigerated pasteurized crabmeat lists a monitoring procedure at the storage critical control point that is not adequate to control the hazard of pathogen growth and toxin formation, including C. botulinum.

Specifically, your plan lists a monitoring method of manually checking the temperature of product (b)(4). However, for storage of refrigerated product, FDA recommends the use of a continuous temperature recording device with a visual check of the recorded data at least once per day.

Your September 6, 2012, response does not propose a correction to this observation, and you have not provided an updated HACCP plan for our evaluation.

4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b).  However, your corrective action plans for refrigerated pasteurized crabmeat to control pathogen hazards at the following CCPs are not appropriate:

a. Your plan’s corrective action at the receiving CCP is “refuse product”. This corrective action does not ensure that the cause of the deviation was corrected. FDA recommends that an appropriate corrective action at the receiving CCP is to discontinue use of the carrier until evidence is obtained that the identified transportation handling practices have been improved.

b. Your plan’s corrective action at the storage CCP of “If temp is outside of critical limit check product temp if product temp is (b)(4) deg or less cooler and repair if crabmeat temp is ovr [sic] (b)(4) destory [sic] product” does not ensure that the root cause of the deviation was investigated and corrected.

 Your September 6, 2012, response does not propose a correction to this observation, and you have not provided an updated HACCP plan for our evaluation.

5.  You must have and implement written verification procedures, to include product specifications and affirmative steps, for ensuring that the fish and fishery products you import into the United States were processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2). However, your firm has no written verification procedures or product specifications, and did not implement an affirmative step for fishery products that you imported, to include:

a. Frozen tilapia that you imported from (b)(4),
b. Frozen cooked whole crawfish with Cajun flavor that you imported from (b)(4).

Your September 6, 2012, response does not propose a correction to this observation, and you have not provided an updated HACCP plan for our evaluation.

6. 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).  However, your firm did not monitor the safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice, with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by dirt and grime build-up in the interior of your machine that makes ice that will make direct contact with seafood such as fresh oysters.

Your September 6, 2012, response does not propose a correction to this sanitation observation.

Additionally, we note that in your response’s discussion of FDA 483 Observation 2, which is in regard to failure to monitor to ensure that refrigerated fishery products have been held at or below an ambient or internal temperature of 40°F throughout transit, you state that you will send (b)(4) devices to a third-party for data download. If it is your intent to monitor this CCP by sending such devices to a third-party for downloading, we question how your receiving employee can determine whether or not fishery products have been held at or below an ambient or internal temperature of 40°F throughout transit, and thus whether or not to receive these items, or to refuse the shipment at the time of delivery.

We may take further action if you do not promptly correct these violations.  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," seize your product(s) and/or enjoin your firm from further violating the Act.

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 documentation with your response, such as HACCP and importer verification records, records that document the performance and results of your firm’s affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 seafood importer establishment operates in compliance with the Act and 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 for your fish or fishery products, including those that you import into the United States.

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 domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.

Please send your reply to the Food and Drug Administration, Attention: Seri L. Essary, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Ms. Essary at (214)253-5335.

Sincerely,

/S/

Reynaldo R. Rodriguez, Jr.
District Director