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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Groomer's Seafood of San Antonio 03-Jun-05

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 75204-3145


 

.

June 3, 2005

05-DAL-WL-17

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTE
D

Mr. Richard D. Groomer, President
Groomer's Seafood of San Antonio
9801 McCuflough Avenue
San Antonio, Texas 78216-4610

Dear Mr. Groomer:

We inspected your firm, Groomer's Seafood of San Antonio, located at 9801 McCullough Avenue, San Antonio, Texas on January 19-20, 26; February, 2, 4, 7-8, 2005. 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 fresh cooked crabmeat, pasteurized cooked crabmeat; thawed, previously frozen, tuna and mahi-mahi 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: 3rd Edition, June 2001 (the Hazard Guide) through links in FDA's home page at http://www.fda.gov.

The deviations that were found during the inspection were as follows:

1. You must conduct, or have conducted for you, 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 plan for "AI! scombroid species Histamine Potentials" does not list the critical control point for thawing frozen vacuum packaged scombroid fish for controlling the food safety hazards of histamine formation and Clostridium botulinum growth and toxin formation. Histamine development is a reasonably likely hazard associated with your scombroid species as a result of time and temperature abuse during the thawing process. Furthermore, the vacuum package creates an additional potential for Clostridium botulinum and toxin formation during refrigerated thawing. Consequently, because this hazard is associated with the packaging type, rather than with the fish species, a critical control point for thawing will apply to any and all of your raw frozen vacuum packed fish. We acknowledge that it is your firm's practice to slit the vacuum package at the start of the thaw process, which will introduce oxygen and thus eliminate the potential for Clostridium botulinum growth and toxin formation. However, if this is the procedure you have implemented and intend to use as your strategy for control of the hazard, your plan needs to include this step as critical to the thawing process. For more information on the control of Clostridium botulinum in raw vacuum packaged products, please refer to Chapter 13 of tile Hazard Guide.

2. You must have a HACCP plan that,at a minimum, lists the critical limits that must be met at each of the critical control points, to comply with 21 CFR Part 123.6(c)(3). A critical limit is defined in 21 CFR Part 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 "All Scombroid Species" does not list an adequate critical limit at the storage critical control point to control histamine development. You list monitoring of storage temperatures at [redacted] hour intervals, however, this interval is not adequate to ensure that intermittent temperature fluctuations do not occur that may lead to abuse of the products. For temperature sensitive products (such as all scombroid species), FDA recommends using an instrument capable of continuously monitoring the temperatures during extended refrigerated storage. In addition, the Agency recommends that firms conduct a visual check of the equipment daily to ensure that it is properly working and that temperatures have been properly maintained. For more information on storage and handling of scombroid species of fish, please refer to Chapter 7 of the Hazard Guide.

3. You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control any foods safety hazards that are reasonably. likely to occur, to comply with 21 CFR Part 123.6(a) and (b). However, your firm does not have a HACCP plan for fresh picked, cooked, ready-to-eat crab meat, to control pathogen growth and toxin formation, nor one for pasteurized crab meat in hermetically sealed metal containers to specif(cally control Clostridium botulinum growth and toxin formation. We acknowledge that these products are included in the product list for your HACCP plan entitled "AI! Shellfish Fresh and Frozen," however, in accordance with 21 CFR Part 123.6(b)(2) a HACCP plan is necessary for each kind of fish and fishery product processed by the processor, with a grouping of fish and fishery products being appropriate only when the food safety hazards, critical control points, critical limits and monitoring procedures are identical. Your current plan lists monitoring associated with shellfish tags to control pathogens and contaminants from the harvest water (i .e., for raw molluscan shellfish) at receiving and storage at a critical limit temperature of [redacted]F. These are not the appropriate hazards and controls for your crab meat products.

In addition, during the inspection, samples of three (3) product labels were collected. Review of the labels found serious violations of the Act and Food Labeling Regulations, Title 29, Code of Federal Regulations, Part 101 (21 CFR Part 101) as follows.

Your thawed tuna loins, swordfish loins, and Mahi-Mahi fillets are misbranded within the meaning of section 403(k) of the Act because their labels fail to declare the chemical preservative ingredients stating both the common or usual name of the ingredient and a separate description of its function as required by 21 CFR 101.22{j).

For example:

  • The frozen vacuum packaged tuna and swordfish loins that you receive are labeled "PROCESSED WITH FILTERED WOOD SMOKE AS A PRESERVATIVE FOR COLOR RETENTION". However, you only label the thawed tuna loins and swordfish loins that you repack in clear plastic bags and distribute, as "TUNA LOIN" and "SWORDFISH LOIN" respectively with no declaration of the name of the preservative and description of its function.

  • The frozen vacuum packaged Mahi-Mahi fillets that you receive are labeled "CO TREATED". Again, you only label the thawed Mahi-Mahi fillets that you repack in clear plastic bags and distribute, as "MAHI MAHI LOIN" with no declaration of the name of the preservative and description of its function.

In addition, these products are misbranded within the meaning of Section 403(e) of the Act, in that they do not list the place of business of the manufacturer, packer, or distributor, as set forth in 21 CFR 141.5(a).

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 things you are doing 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, abeting, or other useful information that would assist us in evaluating your corrections. 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 deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations

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 (214) 253-5312.

Sincerely,

/S/


Dallas District Direct
Michael A. Chapp