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WARNING LETTER

Proceconsa S.A. Procesadora Continental de Alimentos S.A. MARCS-CMS 486514 —


Recipient:
Proceconsa S.A. Procesadora Continental de Alimentos S.A.


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

WARNING LETTER

FEB 4, 2016
VIA EXPRESS DELIVERY
 
Mr. Juan Sebastian Holguin
President
Proceconsa S.A. Procesadora Continental de Alimentos S.A.
Km 21.5 Via Interocianica, Puembo
Quito, 170150, Ecuador
 
Reference No: #486514
 
Dear Mr. Holguin:
 
The U.S. Food and Drug Administration (FDA) inspected your acidified food (AF) firm, Proceconsa S.A. Procesadora Continental de Alimentos S.A., located at Km 21.5 Via Interocianica, Puembo Quito, Ecuador on October 29 – 30, 2015. During that inspection, we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at your firm.
 
As a manufacturer of AF products intended for export to the United States, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of AF products. Regulations specific to the processing of AF products are described in 21 CFR Part 108 and 21 CFR Part 114. As outlined in these regulations, a commercial processor of AF products that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR Part 114 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from such commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor’s products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. In addition, violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR Part 114 renders your AF products adulterated within the meaning of section 402(a)(4) of the Act (21 U.S.C. 342(a)(4)). You can find the Act and the AF regulations through links in FDA’s home page at www.fda.gov.
 
This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviations found at your firm. We acknowledge receipt of your November 19, 2015 email response to the FDA-483 and below are our concerns with regard to your AF products:
 
1.    Your firm failed to provide FDA’s Center for Food Safety and Applied Nutrition (CFSAN), within 60 days after registration and before packing any new product, information on the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process for each acidified food in each container size as required by 21 CFR 108.25(c)(2). Specifically, during our inspection you thermally processed your Heart of Palm Whole in Brine product in (b)(4) retorts. The FDA has no acidified scheduled processes on file under your firm’s registration for Heart of Palm Whole in Brine product thermally processed using (b)(4) retorts.

Your firm is responsible for determining which regulations apply to the products that you manufacture, including whether products you manufacture are considered to be acidified foods, as defined in 21 CFR 114.3(b), subject to the applicable provisions of 21 CFR Parts 108 and 114.  Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication, “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm125439.htm.
 
Further, your firm could not provide evidence that the scheduled processes for the acidified food products that you manufacture were established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods, as required by 21 CFR 114.83. Specifically, during the inspection you admitted that your thermal process in (b)(4) retorts for Heart of Palm Whole in Brine packed in 300x407 and 401x411 cans was not established by qualified persons having expert knowledge. The process validation studies you provided from (b)(4), dated July 11, 2012 and entitled “ESTUDIOS DE PENETRACION DE CALOR Y DISENO DE PROCESO,” translated to “Study of heat penetration and process design” for Whole Palm in Brine 400 and 800 grams were conducted only on your (b)(4) retorts. You also process the product in (b)(4) retorts. You do not have a validated process for Heart of Palm Whole in Brine thermally processed in a (b)(4) retort. According to your records dated November 26, 2014, you processed your Heart of Palm Whole in Brine in (b)(4) at (b)(4) and subsequently shipped the product to the US.

In your November 19, 2015 response, you stated that you contacted your processing authority in order to review your processes, validate them, and train your operators; however, you did not include a timeframe for completion of this correction, or an explanation of how you will process product intended for shipment to the US prior to implementation. If you have implemented this correction, please submit documentation demonstrating such with your response to this letter.
 
2.    Your firm failed to process each acidified food in conformity with at least the scheduled process, as required by 21 CFR 108.25(c)(3). Specifically, your firm’s filed scheduled process for Heart of Palm Whole in Brine (SID (b)(4)) identifies controlled factors of (b)(4), (b)(4), initial temperature (IT) of (b)(4) Step 1 (b)(4), Step 2 (b)(4), Step 3 (b)(4). However, our inspection revealed that your firm processed your acidified Heart of Palm Whole in Brine packed in 300x407 and 401x411 cans using a thermal process conducted in (b)(4) retorts, not a steam tunnel. 

Further, the process validations you provided from your process authority, (b)(4), during our inspection show that the calculated and suggested process times in the study depend on the IT of the product. For example with an IT (b)(4), the suggested process times (b)(4), compared to a product IT (b)(4) has a suggested process time (b)(4). The IT is a critical factor which your firm does not measure, record, or use to adjust your process time as necessary. You are not following either the scheduled process filed with the FDA or the process recommended by your process authority.
 
3.    Your firm failed to maintain processing records showing adherence to the scheduled processes, including records of critical factors intended to ensure a safe product as required by 21 CFR 114.100(b). Specifically,
  • You did not measure the IT during processing of your Heart of Palm Whole in Brine. Your response indicated that you will (b)(4) and will (b)(4). Your response does not include a timeframe for completion of this correction, or an explanation of how you will process product intended for shipment to the US prior to implementation. If you have implemented this correction, please submit documentation demonstrating such with your response to this letter.
  • Processing and production information was not recorded at the time it was observed and by the retort operator. Recorded data should be recorded at the time of observation; however, during the inspection your processing sheets for sterilization start and stop time, which are critical factors to your process were seen pre-filled with time data. Although your response indicated you re-trained the responsible operator, we cannot evaluate the entirety of your response because of lack of supporting records of training or other documentation that demonstrate the corrective actions were adequate. Furthermore, you did not investigate the potential occurrence of similar conduct by your other operators or indicate additional training given to other employees.
4.    Your firm’s operators are not under the supervision of a person who has attended a school approved by the Commissioner for giving instruction in food-handling techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls, and critical factors in acidification, and who has satisfactorily completed the prescribed course of instruction, as required by 21 CFR 108.25(f). In your response you stated that you contacted your thermal processing authority in order to train your Plant Chief, Supervisors and operators; however, we cannot evaluate the entirety of your response because of lack of supporting documentation demonstrating satisfactory completion of instruction or a timeframe for completion of instruction. If you have implemented this correction, please submit documentation demonstrating such with your response to this letter.
 
5.    Your firm failed to record processing deviations in a separate file that details both the deviations and the actions taken, as required by 21 CFR 114.100(c). During our inspection, you could not provide a process deviation file and could not answer questions regarding the number or types of deviations which had occurred in 2015. You explained you would need to go through all of your process records to find the deviations. Maintaining a separate file for process deviations allows you to evaluate and address process deviation trends so you may anticipate and correct future deviations. You responded that you have implemented a digital file to record process deviations; however, we cannot evaluate the entirety of your response because of lack of supporting documentation. If you have implemented this correction, please submit documentation demonstrating such with your response to this letter.
 
6.    Your firm’s required container identification failed to include the establishment where packed, as required by 21 CFR 114.80(b). The manufacturing code you use identifies the product, year of manufacture, the Julian date packed, batch code, brand name reference and pallet number; however, the code does not identify the facility where packed. Your response indicated that you are seeking customer approval of the new can coding system which includes a digit for your facility. You did not provide your proposed new coding system or what you will do to address the deviation pending change to the new code. If you have fully implemented this correction, please submit documentation demonstrating such with your response to this letter.
 
During the inspection, you told our investigator that your firm also processes Heart of Palm Whole without acidified brine. Without acidification to lower the pH below 4.6, the product may be considered a low-acid food packaged in hermetically sealed container (LACF); as such, the product must be processed in accordance with 21 CFR 113. You also said that some of your filed acidified processes in FDA’s LACF database may no longer be in use and process parameters may have changed. Your firm should update the acidified processes filed under your food canning establishment (FCE) by filing new processes and removing or cancelling any process which your company does not manufacturer.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and all applicable regulations, including the AF regulations (21 CFR Parts 108 and 114) 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 Federal Food, Drug, and Cosmetic 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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
 
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to further correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) 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 further action to refuse admission of your imported AF products under section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the AF regulations (21 CFR Part 108 and 114) is Import Alert #99-37. This alert can be found on FDA’s web site at: www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Aleta T. Flores, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: aleta.flores@fda.hhs.gov. Please reference #CMS 486514 on any submissions and within the subject line of any emails to us. You may also contact Aleta T. Flores via email if you have any questions about this letter. 
                                               
Sincerely,
/S/                                                                                   
William A. Correll
Director
Office of Compliance
Center for Food Safety
      and Applied Nutrition

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