Inspections, Compliance, Enforcement, and Criminal Investigations

Granja La Cabana 3/11/15

  

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 Fernández Juncos
San Juan, Puerto Rico 00901-3223
Telephone: (787) 729-8500 
FAX: (787) 729-8826

 

WARNING LETTER
15-SJN-WL-02
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
March 11, 2015
 
Mr. Glidden Martinez, Owner
Granja La Cabaña, Inc.
7504 La Sanche
Utuado, Puerto Rico  00641
 
Dear Mr. Martinez:
 
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at Road 610 Km 1.9, Utuado, Puerto Rico, on December 2 through 10, 2014. During the inspection, FDA found that your facility had serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 118).  Failure to comply with the provisions of 21 CFR 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the PHS Act), 42 U.S.C. § 264(a).  In addition, these violations render your shell eggs adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 342(a)(4), 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.  Our investigators' observations were noted on Form FDA 483, Inspectional Observations, issued to Mr. Joavanny G. Martinez, Manager, on December 10, 2014. You may find the FD&C Act, the PHS Act, and the shell egg regulation through links on FDA’s home page at http://www.fda.gov/.
 
Your significant violations are as follows:
 
1.    You failed to have a written Salmonella Enteritidis (“SE”) prevention plan that includes, at a minimum, the SE prevention measures required by 21 CFR 118.4.  
 
We acknowledge that your January 7, 2015, response to the FDA 483 included a written SE prevention plan.  However, this SE prevention plan does not include sections on pullets and refrigeration procedures which must be included as part of your SE prevention plan to comply with 21 CFR 118.4(a) and 21 CFR 118.4(e), respectively.   
 
2.    You failed to implement appropriate rodent and fly monitoring methods, as required by 21 CFR 118.4(c)(1) and 21 CFR 118.4(c)(2).  You did not use appropriate monitoring methods that allow you to determine when there is unacceptable rodent or fly activity within a poultry house.  Specifically, during the inspection our investigators noted that you did not utilize mechanical traps or glueboards or another appropriate monitoring method in your poultry houses to monitor for rodents, as required by 21 CFR 118.4(c)(1). During the inspection, our investigators also noted that you did not utilize spot cards, Scudder grills, sticky traps or another appropriate fly monitoring method, as required by 21 CFR 118.4(c)(2). Adequate rodent and fly monitoring activities and accurate maintenance of the rodent and fly control monitoring records required by 21 CFR 118.10(a)(3)(ii) are key elements in assuring satisfactory rodent and fly control at your egg laying facility.
 
Your January 7, 2015, response to the FDA 483 states that you have contracted with a pest control company to provide rodent traps around the perimeter of your poultry houses and processing center. Additionally, the written SE prevention plan included with your response has sections on rodent and fly monitoring that call for (b)(4) of rodents and flies and the use of FDA’s recommended rodent index determination and recommended procedures to determine an unacceptable level of fly activity. Although your written SE plan describes the fly monitoring methods that will be used, your written SE plan does not include appropriate methods for achieving satisfactory fly control when monitoring indicates unacceptable fly activity within a poultry house, as required by 21 CFR 118.4(c)(2). We will evaluate the implementation of the rodent and fly monitoring corrective actions during our next inspection of your farm.
 
3.    You failed to have adequate biosecurity measures to ensure that there is no introduction or transfer of SE into or among poultry houses, as required by 21 CFR 118.4(b):
 
a.    You failed to limit visitors on the farm as required by 21 CFR 118.4(b)(1). Specifically, our investigators observed that the front gate to your farm was open to traffic.
b.    You failed to maintain practices that will protect against cross contamination when persons move between poultry houses, as required by 21 CFR 118.4(b)(3).  Specifically, our investigators observed no practices that minimize the risk of cross contamination when persons move between your two poultry houses, such as removing any caked debris from boots or footwear or implementing the use of adequate food dips, etc.
c.    You failed to prevent wild birds from entering poultry houses, as required by 21 CFR 118.4(b)(4).  Specifically, our investigators observed approximately ten wild birds in the poultry houses. We additionally noted that the poultry houses did not have any barriers installed to prevent stray animals from entering them.
 
Your January 7, 2015, response to the FDA 483 states that you will install a controlled access gate to limit visitors to your farm; will maintain dedicated equipment for cleaning each poultry house; have purchased footbaths for entry into each poultry house; and requests more time to install netting to prevent entry of other animals into the poultry houses. We will evaluate the implementation of these corrective actions during our next inspection of your farm.
 
4.    You failed to maintain records documenting your SE prevention measures, as required by 21 CFR 118.10. Specifically:
 
a.    As indicated above, you did not have a written SE prevention plan as required by 21 CFR 118.4. Maintenance of such a plan is required by 21 CFR 118.10(a)(1). 
b.    You did not maintain records documenting compliance with biosecurity measures, as required by 21 CFR 118.10(a)(3)(i). Specifically, our investigators observed that you did not maintain records addressing the limiting of visitors on the farm.  
c.    As indicated above, you did not maintain records of rodent and other pest control measures, as required by 21 CFR 118.10(a)(3)(ii). 
d.    You did not maintain records documenting compliance with refrigeration requirements, as required by 21 CFR 118.10(a)(3)(iv).
 
Your January 7, 2015, response to the FDA 483 includes a written SE prevention plan and forms for documenting SE prevention measures.  However, the forms documenting compliance with biosecurity measures were not filled out; therefore we cannot comment on the adequacy of this correction. We will verify the implementation of your written SE prevention plan and the use of the forms during the next inspection.
 
This letter is not intended to be an all-inclusive list of violations at your facility.  You are responsible for ensuring that your shell egg production facility operates in compliance with all applicable statutes and regulations, including the FD&C Act, the PHS Act, and the shell egg regulation. You also have a responsibility to use procedures to prevent further violations of these statutes and regulations.
 
You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).
 
In addition to the above violations, we also have the following comment:
 
  • The written SE prevention plan provided with your January 7, 2015 response states that you will perform environmental testing for SE in a poultry house when pullets are 14 to 16 weeks of age, when laying hens are 40 to 45 weeks of age, and 4 to 6 weeks after molting. Maintaining records documenting flock age will assist in determining the appropriate age for environmental testing for SE to comply with 21 CFR 118.4(a)(2)(i), 21 CFR 118.5(a), and 21 CFR 118.5(b). These records were not accessible for review for the hens in House 2 at the time of the inspection. 
 
You should respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should outline the specific things you have done or plan to do to correct these violations and prevent their recurrence.  You should include in your response documentation and other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the timeframe within which the remaining corrections will be completed.
 
Your written response should be directed to the Food and Drug Administration, attention: Carlos A. Medina, Compliance Officer, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Medina at (787) 729-8617 or via email at carlosa.medina@fda.hhs.gov. 
 
Sincerely yours,
/S/ 
Maridalia Torres
District Director
San Juan District

Page Last Updated: 11/15/2017
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