Inspections, Compliance, Enforcement, and Criminal Investigations

Don Julio Tropical Food LLC 8/15/18

 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Regulatory Affairs
Division of Human and Animal Food Division IV East
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: (787) 729-8500 

 

August 15, 2018
 
WARNING LETTER
 
18-HAFE4-WL-04/CMS No. 562174
 
VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
 
 
Mr. Ernesto Vázquez Borrero, President
Don Julio Tropical Food LLC.
Ext. La Guadalupe
Calle Guadalupe # 62
Ponce, Puerto Rico  00730
 
Dear Mr. Vázquez Borrero:
 
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility located at Calle Guadalupe # 62, Ponce, Puerto Rico, on May 21, 2018 through June 01, 2018. Our inspection found you have repeat violations of Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations (CFR), Part 110.[1[i]] These violations cause your food product(s) 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 FDA regulations in the CFR through links in FDA's website at www.fda.gov.
 
During our inspection of your facility, our investigator’s observations were noted on a Form FDA 483, Inspectional Observations, issued to you on June 01, 2018.
 
The significant CGMP violations were as follows:
 
1.    You failed to take effective measures to exclude pests from the processing areas and to protect against contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, on 05/21/2018 and 05/22/2018 our investigator observed dead roaches’ parts too numerous to count in your firm's warehouse floor next to ambient temperature raw materials such as sodium benzoate, dry onions, garlic granules, and oregano. You were previously cited for the same or similar violation during the 2009 and 2015 inspections.
 
2.    Your firm failed to take all reasonable precautions to ensure that production procedures do not contribute to contamination from any source, as required by 21 CFR 110.80. Specifically, during the inspection our investigator observed while manufacturing various products with Lot No. 9450, such as "Sofrito Excelencia" (Condiment Mix) and "Ajo Puro" (Raw Grounded Garlic) the following:
  • Employees in the manufacturing area where re-using disposable items as utensils. These were at least five (5) empty plastic bleach containers that were cut in halves and were being re-used as scoops and funnels for collecting and/or dispensing ingredients, processing water, and finished products filling step.
  • Air extractor screen in the production area was filthy and dusty, potentially allowing the falling of dust and dirt into in-process products and uncovered raw ingredients.
  • A pair of rubber gloves used for cleaning purposes were hanging right above exposed "Ajo Puro" (Raw Grounded Garlic) finished product. Repeat observation from our 2009, 2012, and 2015 inspections. 
3.    You must store raw materials in a manner that protects against contamination, as required by 21 CFR 110.80(a)(1). Specifically, on 05/21/2018 and 05/22/2018, our investigator observed:
  • Ingredients such as dry onions, garlic, oregano, citric acid, and sodium benzoate stored in the ambient temperature area on top of soiled and dirty pallets. Additionally, the area was observed dusty, which could potentially contaminate ingredients.
  • Ingredients such as red peppers and green peppers stored in the refrigerator area on pallets against the foam type walls. These foam type walls had missing sections and were soiled with what appears to be mold. In addition, the foam type ceiling was missing sections and soiled with what appears to be mold.
  • Packaging cardboard boxes were stored inside your non-functional and dirty refrigerator and it had soiled walls and damaged ceiling areas.
  • Preservatives ingredients such as salt, sodium benzoate, and citric acid placed in your manufacturing area were not properly labeled. In addition, these ingredients were stored in filthy containers and were kept un-covered while not in use. Repeat observation from our 2010 and 2015 inspections. 
4.    You failed to properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant building that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 110.20(a)(1). Specifically, our investigator observed your firm's warehouse area, where packaging plastic bowls, plastic lids, and glass jar containers were stored, was also used to store waste material, had at least forty (40) not-in-use refrigerators, one (1) not-in-use forklift, one (1) not-in-use 300 gallons’ stainless steel tank, and old carton boxes. In addition, our investigator observed that an approximately 100 square feet area of the ceiling panels installed in your firm's warehouse were detached from the ceiling leaving openings that provide a potential breeding place for pests. Repeat observation from our 2009, 2012, and 2015 inspections.
 
5.    The procedures used for cleaning and sanitizing of utensils must provide adequate cleaning and sanitizing treatment as required by 21 CFR 110.35(d)(5). Specifically,
  • The three (3)-compartment sink used to wash and sanitize glass jars re-used from returned products was not set up in the correct sequence of wash-rinse-sanitize. In addition, your firm manufacturing cleaning area does not have a three (3)-compartment sink and utensils are not properly cleaned while manufacturing is in progress.
  • On 05/21/2018 and 05/22/2018, our investigator observed that plastic utensils were kept inside this single compartment sink and were being cleaned with water and soap alone. Repeat observation from our 2015 inspection. 
6.    Your firm failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7).  Specifically, our investigator observed windows in processing area did not have any type of screening and doors leading to the receiving and/or dispatching of raw materials and finished products have a gap of approximately four (4) inches wide at the bottom. A second door connecting the exterior of the firm with this warehouse had a gap of approximately two (2) inches wide at the bottom. Repeat observation from our 2009 and 2015 inspections. 
 
7.    You failed to maintain buildings, fixtures or other physical facilities in a sanitary condition as required by 21 CFR 110.35(a). Specifically, our investigator observed that the floors in your processing area are not constructed from a material that could be easily cleaned and kept clean. Gaps in between floor tiles had accumulated dirt and black stains that appeared to be mold. In addition, walls in the processing area had sections of missing tiles and showed presence of what appeared to be mold. During the inspection, your firm was formulating "Sofrito" (Condiment Mix) and "Ajo" (Raw Grounded Garlic) finished products. (Repeat observation from our 2009, 2010, and 2015 inspections).
 
We note that you have not provided a written response to the Form FDA 483, Investigator Observations, issued to you on June 01, 2018. Please be aware that without a written response, we are unable to assess your understanding of the observations and any potential corrective actions to voluntarily comply with applicable regulations.
 
In addition, we have determined that your facility is subject to the biennial registration renewal requirement in § 415(a)(3) of the Act, 21 U.S.C. § 350d(a)(3), which requires submission of a renewal registration during the period beginning on October 1 and ending on December 31 of each even-numbered year, and our implementing regulation at 21 CFR Part 1, Subpart H. During the current inspection of your facility, you were advised of this requirement.  Failure to re-register a facility is a prohibited act under § 301(dd) of the Act, 21 U.S.C. § 331 (dd).  Our records indicate that, to date, this facility has not been re-registered with FDA.
 
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
 
We request you register your facility with FDA within fifteen (15) working days from receipt of this letter. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. Alternatively, you may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA’s food facility registration form, Form FDA 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the Agency at the following address:
 
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
 
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility’s registration number using the same method used to submit the registration to FDA.
 
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
 
Section 743 of the Act, [21 USC 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 USC 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 notify this office in writing within fifteen (15) working days from receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including copies of records, photographs or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be implemented.
 
Your reply should be directed to District Director, Food and Drug Administration, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact Ms. Beira Montalvo, Compliance Officer, at (561) 416-1065, Ext. 1108, or via e-mail at Beira.Montalvo@fda.hhs.gov.
                                                                      
Sincerely yours,
/S/ 
Ramon A. Hernandez 
Director, San Juan District
and Program Division Director,
Office of Animal and Human Food Operations,
Division IV East


[1[i]] Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See:  Compliance Date Extensions and Clarifications for FSMA Final Rules.

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