Inspections, Compliance, Enforcement, and Criminal Investigations
Sun Boricua, Inc. 9/18/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Juan District
466 Fernández Juncos
San Juan, Puerto Rico
September 18, 2012
Return Receipt Requested
Mr. Héctor Javier Rullán
Sun Boricua, Inc.
HC-02 Box 7876
Camuy, PR 00627
Dear Mr. Rullán:
The United States Food and Drug Administration (FDA) inspected your seafood manufacturing establishment located at Road 486, Km 0.1, Bo. Quebrada, Camuy, Puerto Rico, from June 01, 2012 through June 06, 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 § 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 seafood products, including your shrimp, lobster, marlin, and crab seafood tacos distributed under the Delicias del Mar brand name, are adulterated, in that they have been held under unsanitary conditions whereby they may have been rendered injurious to health.
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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR § 123.6(a) and (b). However your firm does not have a HACCP plan for your seafood tacos, manufactured with marlin, lobster, shrimp, and/or crab meat to control related food safety hazards such as growth of pathogens, biological toxin formation, and/or scombrotoxin formation.
2. You must have a HACCP plan that lists the critical control points for each identified food safety hazard to comply with 21 CFR § 123.6(c)(2); and establishes the critical limits that must be met at each identified critical control point 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 has not developed nor implemented a HACCP plan for your products, including your variety of seafood products (lobster, marlin, crab and shrimp tacos). There is not a HACCP plan listing activities performed to adequately control biological, chemical and/or physical hazards likely to occur.
We acknowledge receipt of your written response letter on June 13, 2012 to the Inspectional Observations (Form FDA-483) issued to you on June 06, 2012. You submitted a copy of a Hazards Analysis and a HACCP plan developed for your manufacturing facility. Our review of the submitted documentation found it inadequate in that:
1. It is not product specific. Your HACCP plan groups different kinds of fish and fishery products, such as frozen marlin, shrimp, lobster; and refrigerated canned crab meat, that have different food safety hazards, critical control points, critical limits, and procedures required to be identified and performed to comply with 21 CFR § 123.6(b)(2). For instance, your marlin fish product, when compared with your other products, possesses the specific hazard of scombrotoxin (histamine) formation.
2. Your HACCP plan does not identify the “thawing” step as a Critical Control Point for your marlin fish product that possesses the hazard of scombrotoxin (histamine) formation. Scombrotoxin hazard is cumulative and not eliminated by further cooking process. Such fish are not to be exposed to temperatures above 40°F (4.4°C) for more than 12 hours, cumulatively, if any portion of that time is at temperature above 70°F (21°C).
3. Not all of your product hazards are identified such as allergens/additives (sulfites in wild-caught shrimp); and potential metal inclusion (during handling of fish).
4. Your HACCP plan failed to comply with 21 CFR § 123.6(d)(1), since it is undated and unsigned.
5. You did not provide evidence to support that your firm complies with the requirements established under 21 CFR § 123.10 to support that the HACCP plan you provided was developed by an individual who successfully completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the U.S. Food and Drug Administration or who is otherwise qualified through a job experience to perform these functions.
We may take further action if you do not promptly correct these violations. For instance, we may take action to seize your product(s) and/or enjoin your firm from operating. At the conclusion of the inspection on June 06, 2012, you verbally promised our Investigator that you would immediately begin correcting the identified deviations. A HACCP plan, on its own, does not warrant compliance unless it is demonstrated that the HACCP plan is adequate and is being followed.
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:
1. Copy of your HACCP plan. Include evidence to support that your firm complies with the requirements established under 21 CFR § 123.10.
2. Critical Control Points (CCP) Monitoring Records. To comply with 21 CFR § 123.6(c)(4), you must have a HACCP plan that, at minimum, lists appropriate monitoring procedures for each critical control point.
3. Corrective Action Plan. Since you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR § 123.7 (b).
4. Sanitation Conditions Monitoring Records. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current Good Manufacturing Practices requirements in 21 CFR § 110, to comply with 21 CFR § 123.11(b). Sanitation records may be included in the HACCP plan; if you choose to do so, include copy of such records in your response.
In addition, submit any 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 manufacturing establishment operates in compliance with the Act, the seafood HACCP (21 CFR Part 123) and the Current Good Manufacturing Practices (21 CFR Part 110) regulations. 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.
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 mean 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: Mrs. Maridalia Torres, District Director, at 466 Fernández Juncos Avenue, San Juan, PR 00901-3223. If you have questions regarding any issues in this letter, please contact Mrs. Marilyn Santiago, Compliance Officer, via email at Marilyn.Santiago@fda.hhs.gov or via telephone at (787) 474-9535.
San Juan District
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