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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Seafood Wholesalers, Limited 7/29/13

  

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 

July 29, 2013

2013-DAL-WL-043
WARNING LETTER
UPS OVERNIGHT
 
Shane Islam, General Partner
Seafood Wholesalers, Limited
6060B Southwest Freeway
Houston, TX 77257
 
Dear Mr. Islam:
 
We inspected your seafood processing facility, located at 6060B Southwest Freeway, Houston, Texas, on February 25 through March 14, 2013. 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. 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 fresh scombroid species, crabmeat, and vacuum-packaged smoked salmon products 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 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, review of your firm’s HACCP plan for pasteurized crabmeat reveals that it lists a critical limit at the receiving critical control point (CCP) that is not adequate to control pathogen growth and toxin formation, including that of C. botulinum. Specifically, your plan’s critical limit of, “all pasteurized crabmeat received at (b)(4) or below” does not ensure that refrigerated fishery products have been held at or below an ambient or internal temperature of 40°F throughout transit.
 
2.    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, review of your firm’s HACCP plans for ready-to-eat crabmeat, pasteurized crabmeat, and vacuum packaged smoked salmon reveals that they all list a monitoring procedure frequency at the storage CCP that is not adequate to control pathogens.
 
Specifically, your frequency is “check reading (b)(4) & visually check temp. (b)(4) during work hours,” and during the inspection the investigator was informed that your firm’s practice is to manually check the cooler temperature every (b)(4) with a thermometer, and download the continuous digital monitoring of the cooler temperature on a (b)(4)basis. However, FDA recommends that your monitoring procedure includes checking the recorded digital temperature data once per day to ensure that the critical limit has consistently been met.
 
3.    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 of continuous monitoring of the cooler temperature at the storage CCPs to control the hazard of scombrotoxin formation as listed in your HACCP plan for scombroid species, or to control the pathogen hazard in the HACCP plans for crabmeat and vacuum packaged smoked salmon.
 
Specifically:

a.    There was no continuous temperature monitoring device in the cooler where scombroid species were stored.

b.    Review of the records that your firm provided for the continuous temperature monitoring of the cooler in which ready-to-eat crabmeat, pasteurized crabmeat, and vacuum packaged smoked salmon are held reveals that there are gaps in the data, during which time there is no evidence that continuous temperature monitoring was occurring, including:

 

  • From 2/5/13 at 14:47 until 2/6/13 at 05:35, a time period of almost fifteen hours.
  • From 1/10/12 at 09:29 until 1/11/12 at 05:40, a time period of twenty hours.
 
We acknowledge that by the end of the inspection your firm installed a digital temperature monitoring device in the cooler in which scombroid species are held. We recommend that you ensure that your monitoring of all coolers is continuous and that any necessary interruptions in monitoring, such as when downloading data, are as brief as possible.
 
Further, in addition to digital and manual temperature checks, your plans for scombroid species and ready-to-eat crabmeat also include checking the adequacy of the ice of product in storage to monitor the “product covered in ice throughout storage” portion of your critical limits. However, review of photographs taken during the inspection reveals that both fresh tuna and ready-to-eat crabmeat in storage were not covered in ice.
 
4.    You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control the hazard of C. botulinum when your process for vacuum-packaged smoked salmon deviated from your critical limit at the receiving CCP. 
 
Specifically, your monitoring records reveal that on 2/26/13 you received vacuum-packaged smoked salmon that was (b)(4)F. Your critical limit for this product at receipt is “all smoked fish received at (b)(4) or below.” However, your firm failed to follow your corrective action of “reject lot,” and instead accepted the shipment without implementing any corrective action plan.
 
5.    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, review of your firm’s HACCP plan for pasteurized crabmeat reveals your corrective action plans are not appropriate at the receiving and storage CCPs to control pathogen growth and toxin formation, as follows:

a.    Your plan’s corrective action at the receiving CCP is “reject lot”. This corrective action does not ensure that the cause of the deviation was corrected. Therefore, in addition to rejection of the lot, FDA recommends that your corrective action at the receiving CCP includes discontinuing 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 “hold lot and evaluate based and [sic] total time/temp exposure. Destroy lot if time/temp exceeds (b)(4) hrs above (b)(4)” does not ensure that the root cause of the deviation was investigated and corrected.

 
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.
 
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). 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 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.
 
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.
 
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.
Dallas District Director