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WARNING LETTER

Casa Pablo's Salsa LLC MARCS-CMS 562159 —

Product:
Food & Beverages
Food & Color Additives

Recipient:
Recipient Name
Dominic Alonzo
Recipient Title
Managing Member
Casa Pablo's Salsa LLC
Casa Pablo's Salsa LLC

938 Phillips Street #3

Missoula, MT 59802-2624
United States

Issuing Office:
Seattle District Office

United States


October 16, 2018

OVERNIGHT DELIVERY
SIGNATURE REQUIRED

In reply, refer to: WL CMS 562159

Dominic Alonzo, Managing Member
Robert Powell, Managing Member
Casa Pablo’s Salsa LLC
938 Phillips Street #3
Missoula, Montana 59802-2624

WARNING LETTER

Dear Messrs. Alonzo and Powell:

The U.S. Food and Drug Administration (FDA) inspected your fresh, refrigerated, and acidified salsa manufacturing facility, Casa Pablo’s Salsa LLC, located at 938 Phillips Street #3, Missoula, Montana, on May 29, 2018, through June 20, 2018.  The inspection revealed serious violations of the Emergency Permit Control regulation, Title 21, Code of Federal Regulations, Part 108 (21 CFR 108), the Acidified Foods regulation, 21 CFR Part 114, and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods regulation (CGMP and PC rule), 21 CFR Part 117.  At the conclusion of the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations (FDA-483) that lists the serious violations found at your facility.  To date, we have not received any correspondence from your firm in response to the FDA-483.

Based on FDA’s findings during the inspection, we have determined that your fresh, refrigerated, and acidified salsa products are 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 whereby they may have been rendered injurious to health.

As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and good manufacturing practices.  The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Act [21 U.S.C. § 344].  A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114. 

The CGMP and PC rule includes updated CGMPs in subpart B with associated requirements for employee training and records in subparts A and F.  Although not covered by this inspection, you also are subject to the preventive control requirements in the CGMP & PC rule (primarily located in subparts C and G).  Under those requirements, a covered food facility must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act [21 U.S.C. § 342 and § 343(w)].  Further, a covered food facility must have a written food safety plan that includes a written hazard analysis and written preventive controls that are appropriate to the facility and food (i.e., process controls, food allergen controls, sanitation controls, recall plan, and a supply chain program as necessary).  Other requirements include employee training (subpart A) and records (subpart F).  Exemptions (21 CFR 117.5) and modified requirements (subpart D) are applicable to certain operations.  As an acidified food processor, your food safety program should address the food safety hazard of Clostridium botulinum.  You can find the Act, the Emergency Permit Control regulation, the Acidified Food regulation, and the CGMP and PC rule through links on FDA’s home page at www.fda.gov.

Violations of the Acidified Foods requirements:
During an inspection of your facility, an FDA investigator observed the following significant violations of the acidified food regulations (AF), Title 21, Code of Federal Regulations, Parts 108 and 114 (21 CFR 108 and 21 CFR 114):
 
  1. As a commercial processor engaged in the (b)(4) processing of acidified foods, you must, no later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled process including conditions for (b)(4) processing and control of pH, salt, sugar, and preservative level, and source and date of the established process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2).  However, our inspection revealed that you failed to file a scheduled process with FDA for your firm’s shelf-stable hot and medium Casa Pablo’s Salsa in one-gallon glass jars and 12-ounce and 16-ounce long neck containers.  This product has been identified as an acidified food by your process authority.

Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method).  More information on registration and filing can be found in the publication “Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in electronic or Paper Format” available at  
https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm309376.htm.

 
  1. You must maintain processing and production records showing adherence to a scheduled process, including records of pH measurements and other critical factors, as required by 21 CFR 114.100(b).  During the inspection, our investigator reviewed (b)(4) processing records for Casa Pablo’s salsa (acidified) manufactured between February 2014 and February 2018; a letter, dated May 17, 2012, from your process authority; and your product sales documentation.  The letter from your process authority identifies the following as critical factors for your hot and medium acidified salsa products: a finished equilibrium pH of (b)(4) or lower; the product must be brought to at least (b)(4)˚F for at least (b)(4) after which the filling process may begin; product temperature during the filling process should be maintained above (b)(4)˚F through the filling process; the entire contents of each finished container must be at or above (b)(4)˚F when the closures (lids) are applied; and the containers must be (b)(4) for at least (b)(4) before the finished containers are cooled.  Review of the processing documents revealed that you do not monitor the maintenance of the product temperature at or above (b)(4)˚F throughout the filling process.  In addition, none of the (b)(4) processing records reviewed included documentation of (b)(4) of the finished containers for at least (b)(4).  The cook time and temperature were recorded on only (b)(4) of (b)(4) processing records, finished equilibrium pH was recorded on only (b)(4) of (b)(4) thermal processing records, and the product filling temperature and time were incomplete or absent on (b)(4) of (b)(4) thermal processing records.  Finally, no production records were prepared for an additional (b)(4) production days.
 
  1. You must exercise sufficient control, including frequent testing and recording of results, so that the finished equilibrium pH values for acidified foods are not higher than 4.6, as required by 21 CFR 114.80(a)(2).  However, review of your production records for Casa Pablo’s salsa (acidified) manufactured between February 2014 and February 2018, indicated that you did not measure equilibrium pH of your finished product on (b)(4).  Further, finished equilibrium pH values were not tested or recorded for an additional (b)(4) production days for which no production records were prepared at all.
 
  1. You must maintain records identifying initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use, as required by 21 CFR 114.100(d).  However, during the inspection, your employee stated that you do not maintain distribution records for specific food lots for your acidified food products.
 
  1. You must prepare and maintain current procedures for recalling products that may be injurious to health; for identifying, collecting, warehousing, and controlling products; for determining the effectiveness of recalls; for notifying FDA of any recalls; and for implementing recall programs, as required by 21 CFR 108.25(e).  However, during the inspection, your employee stated you do not have a written recall plan and have not implemented recall procedures or programs for your acidified food products.

Violations of the Current Good Manufacturing Practice requirements:
During an inspection of your facility, an FDA investigator observed the following significant violations of subpart B of the CGMP & PC rule:
 
  1. You did not maintain your equipment, including utensils and food containers, in an adequate condition through appropriate cleaning and sanitizing as necessary, as required by 21 CFR 117.80(c)(1).  Additionally, steps such as washing, trimming, and cutting must be performed to protect food against contamination, and food must be protected from contaminants that may drip, drain, or be drawn into the food, to comply with 21 CFR 117.80(c)(10). However, during the inspection of your facility, the FDA investigator observed the following:
    1. On June 13, 2018, food debris was observed on the dicing blade, chopping blade, and chute for the (b)(4) machine.  At the time of this observation, this piece of equipment was identified as clean and ready for use, and subsequently was observed used in the production of salsa products.
    2. On May 29, 2018, debris was observed in and on (b)(4) white containers used to store salsa.  These containers were identified as clean, sanitized, and ready for use.
    3. On June 4, 2018, red residue was observed in the well at the bottom of the (b)(4) where the outlet pipe is located.  This piece of food manufacturing equipment was identified as clean, sanitized, and ready for use.
    4. On May 29, 2018, a radio was observed stored on and in direct contact with the food contact side of lids used in the salsa storage.  These lids were identified as ready for use.
    5. On May 29, 2018, cleaned and sanitized utensils were set to dry in pooled water adjacent to the third compartment of the dishwashing sink.
    6. On May 30, 2018, food product residue was observed inside the (b)(4) nozzle being used to wash tomatoes.  This (b)(4) nozzle is also used for (b)(4) in salsa.
 
  1. You did not maintain buildings, fixtures, and other physical facilities in a clean and sanitary condition, and in repair adequate to prevent food from being adulterated, as required by 21 CFR 117.35(a).  Specifically, on May 30, 2018, our investigator observed exposed insulation in the ceiling of your warehouse where finished product packaging is stored.  This insulation was observed hanging from the ceiling over exposed finished product packaging.
 
  1. You did not take adequate measures to protect against the inclusion of metal or other extraneous matter in food, as required by 117.80(c)(8).  Specifically, on May 30, 2018, our investigator observed unshielded light bulbs directly over exposed raw ingredients and a partially opened (b)(4) container of in-process salsa in the walk-in refrigerator.
 
  1. You did not ensure that all persons working in direct contact with food, food-contact surfaces, and food packaging material conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 117.10(b).  Specifically, on May 30, 2018, our investigator observed an employee handling clean produce with gloved hands after touching non-food contact surfaces such as a soiled refrigerator door handle and boxes with the same gloved hands.

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products.  You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws.  You should take prompt action to correct the violations noted in this letter.  Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, 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 determining 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.

You should respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should include each step that has been taken or will be taken to correction the violations and prevent their recurrence.  If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed.  Please include copies of any documentation demonstrating that corrective actions have been made.  If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your written response to the U.S. Food and Drug Administration, Seattle District, 22215 26th Avenue SE, Suite 210, Bothell, Washington, 98021-4421, to the attention of CDR Cynthia White, Compliance Officer.  If you have any questions about this letter, please contact CDR White at (425) 302-0422. 
                                                                                                                                               
Sincerely,

/S/
Miriam R. Burbach                                                                                                                         
District Director

Program Division Director
Office of Human and Animal Foods
Division West VI

cc:    Montana Department of Public
         Health and Human Services
         Cogswell Building
         P.O. Box 202951
         Helena, Montana 59620-2951
        
         Gaylord S. Barnhill, Supervisor                   
         Casa Pablo’s Salsa, LLC
         938 Phillips Street #3
         Missoula, Montana 59802-2624