Inspections, Compliance, Enforcement, and Criminal Investigations

Sucesores De Esmoris & Co., Inc. 3/7/17

 

  

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San Juan District
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: (787) 729-8500

 

March 7, 2017
 
WARNING LETTER
 
 
17-SJN-WL-05 / CMS No. 518991
 
VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
 
 
Mr. James Fox
President
Sucesores De Esmoris & Co., Inc.
5 Comercio St.
Mayaguez, Puerto Rico 00680
 
Dear Mr. Fox:
 
The United States Food and Drug Administration (FDA) inspected your food warehouse and repacking establishment located at 5 Comercio St. Mayaguez, PR, from October 31 through November 18, 2016 (all dates not inclusive). We found that you have serious violations of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP), Title 21, Code of Federal Regulations, Part 110 (21 CFR § 110). These violations cause your human food product(s) that you store and repack, including your dried grains, wheat and corn flour and cheese, to be 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)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health. 
 
You may find the Act and Title 21, Code of Federal Regulations, Part 110 (21 CFR § 110) through links in FDA's website at www.fda.gov.
 
Your significant CGMP violations were as follows:
 
1.    Your firm failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Additionally, your firm failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, during inspection our investigator observed the following:
  • Evidence of pests activity (what appears to be insect parts, dead cockroaches, and rodent pellets) was observed throughout your facility. 
  • The main front door that leads to the warehouse, where food is stored and dried grains repackaging operations are conducted, was opened at all times without screening protection.
In your written response, dated December 7, 2016, you recognize the presence of mice in your facility,but you failed to provide a strategy for pests’ control. Further, your response confirms that your facility still provides for entry of pests, as your main front door remains without screening protection.
 
2.    Your firm failed to maintain buildings, fixtures, or other physical facilities in sanitary conditions as required by 21 CFR Part 110.35(a). Specifically, during inspection, our investigator observed the following throughout your facility:
  • What appears to be insect parts, dead cockroaches, and rodent pellets;
  • Accumulation of what seems to be filth and food debris (spilled food product), which had not been removed after each production’s day; observed on the flooring underneath and around repackaging equipment.
In your written response, dated December 7, 2016, you failed to explain your actions taken to clean your establishment. You failed to propose adequate corrective actions to control entry of pests, and preventive actions to avoid recurrence. 
 
We also note that you do not calibrate the thermometers you use to measure your walk-in coolers temperature.  According to requirements established under 21 CFR Part 110.40(f), instruments used for measuring conditions (i.e. recording temperature) that control or prevent the growth of undesirable microorganisms in food (e.g., cheese) shall be accurate and adequately maintained. Your response is not indicating whether you will be calibrating your thermometers and/or implementing a frequency for verification and recalibration, in order to demonstrate and document your instruments’ accuracy, and to adequately maintain them.
 
Further, your facility should be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair, as required by 21 CFR Part 110.20(b)(4).
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your food warehouse and repacking establishment operates in compliance with the Act and the Current Good Manufacturing Practices regulation (21 CFR Part 110), and all other regulations that apply. 
 
You should take prompt action to correct these violations. Failure to promptly correct and prevent the recurrence of these deviations may result in regulatory action such as a seizure or injunction. You should respond in writing within fifteen (15) working days from the date you receive this letter. Your response should include specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or other violations, from reoccurring.  
 
If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
 
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)). 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..
 
If you have any questions about this letter, you may contact Compliance Officer, Marilyn Santiago at (787) 729-8707, or by electronic mail at: marilyn.santiago@fda.hhs.gov
 
Your response to this letter 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.
 
Sincerely yours,
/S/ 
Maridalia Torres 
Director
San Juan District

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