Hickory Smokehouse Miami, Inc.

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Florida District 555 Winderley Place, Suite 200 Maitland, Florida 32751   Telephone: 407-475-4700 FAX: 407-475-4770

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

WARNING LETTER

FLA-11-35

August 1, 2011

 

Stephen T. Rose

President

Hickory Smokehouse Miami, Inc.

2324 West 79^th Street

Hialeah, FL 33016

                                                                                               

Dear Mr. Rose:

 

The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 2324 West 79^th Street, Hialeah, FL 33016, on April 4-7, 2011.  The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 and 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)]. Accordingly, your cold smoked, cured, vacuum-packed, refrigerated, ready-to-eat 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, the food CGMP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links on FDA's internet website home page at www.fda.gov.

 

Your significant deviations to the seafood HACCP and food CGMP regulations were as follows:

  

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 continuously monitoring the temperatures of the coolers and smoke room with a visual check of the continuous recording thermometers at least once a day at thawing, smoking, and conditioning critical control points to control pathogen growth and toxin formation, including Clostridium botulinum (C. botulinum) listed in your HACCP plan for cold smoked, cured, vacuum-packed, refrigerated, ready-to-eat salmon products (RTE cold smoked salmon products).

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, your firm’s HACCP plan for RTE cold smoked salmon products lists a critical limit, (b)(4) at the smoking CCP that is not adequate to control the significant hazard of pathogen growth, including C. botulinum, in that the minimum and maximum time periods referenced in the critical limit are not specific to the various sizes of RTE cold smoked salmon products manufactured by your firm (e.g., 1-2, 1-3, 2-2.5, 2-3, 3-4, and 4-5 lbs. size fillets). 

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 RTE cold smoked salmon products lists monitoring procedures at the curing and smoking critical control points that are not adequate to control pathogen growth and toxin formation, including C. botulinum. Specifically:

A.    The monitoring procedure for the curing critical control point states in part, (b)(4) Validate post smoke w/lab." However, the documentation you provided to us during the inspection was inadequate in that “CURED SALMON VALIDATION STUDY” makes no reference to minimum curing times and “PROCESS SPECIFICATION: Scientific Study” indicates a minimum cure time of (b)(4) but only for 3-4 lbs. size fillets and not for any of the other sizes of RTE cold smoked salmon products manufactured by your firm (e.g., 1-2, 1-3, 2-2.5, 2-3, and 4-5 lbs. size fillets).

B.    The monitoring procedure for the smoking critical control point states, “Smoke room temp [,]” although the critical limit for the smoking critical control point lists time (b)(4) as well as temperature (b)(4) as factors to be monitored in the smoking process.

C.    In addition, this critical control point, which lists critical limits as (b)(4) does not include any monitoring activities associated with the listed water phase salt (WPS) levels. For examples, when listing critical limits of (b)(4), appropriate corresponding monitoring would involve testing finished product to ensure that each batch achieved the listed critical limits.   Alternatively, your firm needs to establish, through a validated study, the processing parameters necessary to ensure that each batch is properly processed. Additionally, because your firm is including corrective actions in your HACCP plan, the corrective actions at this critical control point must prevent distribution of adulterated products and correct the cause of the deviation.

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 plan for RTE cold smoked salmon products at the curing CCP to control the significant hazard of pathogen growth, including C. botulinum, (b)(4) is not appropriate in that the adequacy of the proposed corrective action to regain control over the critical limit deviation has not been established by a scientific study.

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 significant hazard of pathogen growth and toxin formation, including C. botulinum, when your process for RTE salmon products deviated from your critical limits at the curing and smoking critical control point. Specifically, our review of your firm’s batch records for RTE smoked salmon products revealed that for seventeen (17) out of forty-three (43) processing days between August 17, 2010, and February 18, 2011, your firm took no corrective action when the recorded product curing and smoking times failed to comply with the following minimum and maximum curing and smoking time schedule being followed by your firm (as verbally provided to our Investigators by Jason A. Alonen, Vice President of Hickory Smokehouse Miami, Inc.): 

 

size of fillet (pounds)	minimum time (hours)	maximum time (hours)
(b)(4)	(b)(4)	(b)(4)
(b)(4)	(b)(4)	(b)(4)
(b)(4)	(b)(4)	(b)(4)
(b)(4) (b)(4)	(b)(4)	(b)(4)
(b)(4)	(b)(4)	(b)(4)

 

You must conduct food manufacturing operations under such conditions and controls as are necessary to minimize the contamination of food to comply with 21 CFR 110.80(b)(2). However, your firm was not rinsing the acidified sodium chlorite solution off of your RTE smoked salmon products prior to packaging although the technical data sheet your firm received from the distributor of the solution states, “(b)(4).” See 21 CFR 173.325(d).

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 Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product; Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants. As evidenced by:

A.    During your firm’s RTE cold smoked salmon manufacturing operations on April 6, 2011, your employees were observed routinely touching objects and surfaces that had not been cleaned and sanitized (e.g., garbage bags, trash can lids, and door handles) with their gloved hands and then handling RTE cold smoked salmon (i.e., coming into direct contact with the finished product) without performing proper hand washing and glove changing procedures between tasks.

 

B.    The rims of at least two (2) plastic bins used in the RTE cold smoked salmon curing process were encrusted with a black residue from previous curing operations that could not be removed by washing. The referenced bins were also cracked and chipped and, therefore, were unable to be cleaned and sanitized properly.

 

C.    Your firm was warehousing finished product packaging materials for RTE cold smoked salmon products (e.g., gold and blue colored plastic boards) in such a way as to accumulate dust and debris on the packaging materials.

 

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, your firm’s HACCP plan for cured fish lists critical limits “Fillets/ product are hard on receipt for frozen, or gel packs are hard for receiving fresh”, at the receiving critical control point that are not adequate to control pathogen growth, and toxin formation including C. botulinum. Specifically, the critical limits associated with only monitoring that the gel packs are frozen does not ensure that adequate temperatures were maintained during transit to your facility. FDA recommends that in order to ensure adequate temperatures (i.e., at or below 40º F) during transit, firms monitor to ensure an adequate quantity of gel packs that have remained frozen; and additionally that firms monitor product temperatures (i.e., internal or surface) to ensure products were maintained at 40º F.  

 

Please refer to Chapter 13 of the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition for additional information related to the hazard of pathogen growth and toxin formation including C. botulinum Formation and appropriate control strategies for your products.

 

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 took a corrective action when your process for cured fish deviated from your critical limits at the receiving, thawing, curing, smoking, and in transit/cold-storage critical control points that were not adequate to control pathogen growth and toxin formation including C. botulinum. Specifically, these corrective action plans do not resolve how the cause of the deviation will be corrected.

We also note your firm indicates usage of a (b)(4) for the reduction of bacteria in the water supply. This is considered to be a high limit for the water supply. We note in the Sanitation Control Procedures for Processing Fish and Fishery Products (First edition 2000- page 2-21) - for chlorine levels in plant water 3-10 ppm. The higher end indicates the maximum permitted without a required rinse and surfaces must drain.

FDA acknowledges receipt of Hickory House’s response to the Form FDA 483, Inspectional Observations (FDA 483), issued to Hickory Smokehouse Miami, Inc., at the close of the current inspection. In the response to the FDA 483, which was signed by Jason A. Alonen, Vice President, Mr. Alonen stated that Hickory House would be hiring a consultant to assist your firm in correcting a majority of the seafood HACCP observations listed on the FDA 483 and that the food CGMP observations had already been corrected or would be corrected by the end of May 2011. He also stated that your firm was actively working on having someone at the firm trained in seafood HACCP before July 1, 2011. However, because you failed to include any documentation to support your corrective actions, we cannot evaluate the adequacy of your response. 

Misbranding

 

Your Fjord Superior Smoked Salmon Norwegian Cure is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. In particular, your ingredient statement fails to list the ingredients for the Palmer House Macknight Smokehouse & Hickory House salt/sugar cure which is comprised in part of brown sugar, propylene glycol, caramel powder and natural flavorings [21 CFR 101.4(a)(1)]. Your ingredient statement should be an accurate list of all the ingredients that are used in the product’s manufacture.

 

The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food. 

 

Your Fjord Superior Smoked Salmon Norwegian Cure is misbranded within the meaning of section 403(q)(1) of the Act [21 U.S.C. § 343(q)(1)] because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example: 

• Your product does not express calories from fat to the nearest 10-calorie increment when greater than 50 calories as required by 21 CFR 101.9(c)(1)(ii). Your product declares Calories from fat as 81.
• Your product failed to bear a statement of the number of grams of Trans Fat in accordance with 21 CFR 101.9(c)(2)(ii).
• Your product failed to declare the Servings Per Container as required by 21 CFR 101.9(d)(3)(ii). 

For additional information on General Food Labeling requirements go to http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm.

 

We may take further action if you do not promptly correct these violations. For instance, we may initiate legal proceedings to seize violative products 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.

 

We also note, your net quantity of contents statement is not declared on the principal display panel in accordance with 21 CFR 101.105(f).

 

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 attention of Matthew B. Thomaston, Compliance Officer, at the following address: FDA, Florida District Office, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Mr. Thomaston at (407) 475-4728.

 

Sincerely,

/S/

Edwin Ramos

Acting Director, Florida District

 

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