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  5. Empresas Barsan, Inc. - 05/06/2014
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Empresas Barsan, Inc.

Empresas Barsan, Inc.

United States

Issuing Office:
San Juan District Office

United States


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
San Juan District
Compliance Branch
466 Fernandez Juncos
San Juan, Puerto Rico
Telephone: 787-729-8500
FAX: 787-729-8765 


May 6, 2014
Return Receipt Requested
Mr. Vicente Sanchez
Empresas Barsan Inc
Bldg M1214, C Street
Barrio Palmas Industrial Park
Cataño, PR 00962
Dear Mr. Sánchez:
The U.S. Food and Drug Administration (FDA) inspected your seafood, turnovers, and corn sticks manufacturing facility located at Bldg M1214, C Street, Barrio Palmas Industrial Park, Cataño, PR, from 01/17/2014 through 02/05/2014. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 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 products (tacos dough and shells, pizza flavored turnovers, seafood tacos and corn sticks) 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:
Seafood HACCP violations:
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 your seafood products “Tacos Mariscada” (Seafood mixture tacos), “Tacos Juey” (Crabmeat tacos), and “Tacos Camarones” (Shrimp tacos), manufactured with imitation crab meat, shrimps, octopus, squid, and Alaskan Pollock, do not list the food safety hazards of pathogen growth and toxin formation such as Clostridium botulinum, Staphylococcus aureus, and undeclared allergenic substances.
With regard to the safety hazards that are reasonably likely to occur for your fish and fishery products, we suggest that your firm consider the need for the following critical control points to be included in your revised HACCP plan:
a.        thawing of the fish and fishery products – FDA recommends including a thawing critical control point to ensure that the products are thawed under refrigerated conditions (i.e., 40° F or below), along with continuous monitoring and recording of the time and temperatures to control pathogen growth, including Clostridium botulinum growth and toxin formation in those products that are packaged in oxygen impermeable container.  
b.      cooling - FDA recommends including a cooling critical control point for rapid cooling of cooked products prior to the start of the assembling step, to prevent post process contamination and/or pathogen growth as a result of time and temperature abuse. Cooling is particularly important because your firm manipulates the products (i.e., handles the products) following the cook/cool steps. Consequently, your firm needs to ensure that the products are completely cooled before the start of the assembling process, in order to prevent the potential for pathogen growth, specifically Staphylococcus aureus growth and toxin formation as a result of time and temperature abuse. 
c.       cold storage of product -  FDA recommends including critical control points for any cold storage steps ensure that the products are stored at or below 40° F to control pathogen growth as a result of time and temperature abuse.   
d.      label review - FDA recommends conducting a label review of each lot of labels, during production, to control the hazard of undeclared allergenic substances. The label review should ensure, for example, that the appropriate labels are used for each type of product and to ensure that all allergenic substances are accurately listed on those labels.
cGMP violations:
1.      Effective measures are not being taken by your firm to exclude pests from the processing areas and protect against contamination of food on the premises by pests to comply with 21 CFR 110.35(c). For instance,
a.       On 01/17/2014 and 01/23/2014, evidence of cockroaches’ activity was observed in your processing areas. 
2.      Failure to maintain buildings, fixtures, and physical facilities in repair sufficient to prevent food from becoming adulterated accordingly with 21 CFR 110.35(a). For instance,
a.       Misplaced ceiling tiles and ceiling gaps were observed in your facilities’ kitchen right over the workstations, and on different areas of the manufacturing facilities. There were holes and detached panels on the kitchen walls; and roaches were observed coming out from those areas.
On 02/28/2014 we received your written response to the FDA-483 form dated 02/05/2014, issued to your firm during closing of inspection.  We have completed review of your written response, and found that your corrections were not comprehensive and additional evidence is needed to demonstrate sustained compliance with applicable regulatory requirements. For example, your firm did not provide a revised copy of your HACCP plan.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you have taken to correct these violations. Your response should include documentation, such as a copy of any revised HACCP plan or plans; at least five (5) completed production days-worth of monitoring records to demonstrate that you have implemented the revised plan or plans; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. 
If you do not respond or if we find your response inadequate, we may take further action. 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 February 05, 2014, you committed to implement corrective and preventive actions concerning the referenced 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. 
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.
Additionally, 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 foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign 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 consider providing a copy of this letter to your US Agent.
Your response should be sent to the Food and Drug Administration, San Juan District Office, 466 Fernández Juncos Avenue, San Juan, PR 00901-3223, to the attention of Ms. Maridalia Torres, District Director.
If you have any questions about this letter, you can contact Compliance Officer Marilyn Santiago at 787-729-8707, or by electronic mail at: marilyn.santiago@fda.hhs.gov.
Maridalia Torres
San Juan District Director


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