Inspections, Compliance, Enforcement, and Criminal Investigations

Maria Distribution Sarl 9/24/14

  

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
SEPT 24, 2014  
 
VIA EXPRESS DELIVERY
 
Mrs. Mariama Mbodji, Director General
Maria Distribution Sarl
K.M. 14 Rte de Rufisque
Lot QB derriere la voie ferree
Dakar, Senegal
 
Reference No. 432256
 
Dear Mrs. Mbodji:
 
The U.S. Food and Drug Administration (FDA) inspected your food facility located at K.M. 14 Rte de Rufisque, Lot QB derriere la voie ferree, Dakar, Senegal on January 9-10, 2014. 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 108)) and the Acidified Foods regulation (21 CFR 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. We acknowledge receipt of email correspondences from your firm on February 7, 2014 and August 8, 2014; however, the corrective actions included in your responses do not adequately address the observations listed on the FDA-483 as described below.
 
As a manufacturer of acidified food products intended for export to the United States, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act) and all applicable federal regulations. Regulations specific to the processing of acidified food products are described in 21 CFR 108 and 21 CFR 114. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR 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 a 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. Violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR 114 renders your acidified food 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 Acidified Foods regulations through links in FDA’s home page at www.fda.gov.
 
Your significant violations are as follows:
 
1.    As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide FDA information as to 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). However, you failed to file a scheduled process with FDA for the Pepper Sauce (Habanero) packaged in 450g (16 oz.) and 250g (8.8 oz.) glass jars. We acknowledge your attempt to submit process filings to FDA on January 10, 2014 for your two container sizes of Pepper Sauce; however, these filings were returned on February 27, 2014 and need to be re-submitted in order to comply with 21 CFR 108.25(c)(2). In addition, these processes must be established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods as required by 21 CFR 114.83.
 
Scheduled process information for acidified 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/guidancedocumentsregulatoryinformation/acidifiedlacf/default.htm.
 
2.    Your firm failed to exercise sufficient control including frequent testing so that the finished equilibrium pH values are not higher than 4.6 as required by 21 CFR 114.80(a)(2). Specifically, your firm tests the finished equilibrium pH of your Pepper Sauce just prior to filling when the temperature is (b)(4)°C and does not test the equilibrium pH after (b)(4) when the product has cooled. Your response states that you are taking pH (b)(4) after cooling and that (b)(4) total pH measurements are taken; however, your response did not include any actual processing records that demonstrate your implementation of this new procedure and adherence to your firm’s scheduled process.
 
3.    Your firm failed to mark each container with an identifying code specifying the establishment where the product was packed and the product contained therein as required by 21 CFR 114.80(b). Specifically, the manufacturing code displayed on your labels only identifies an expiration date and does not identify the establishment where the product was packed or the product contained therein. Your response states that your label will bear the date of production and the expiration date; however, you did not include a code for the establishment where the product was packed or the product contained therein.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. Responding in English will help to assist us in our review of your documentation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported acidified food 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 Acidified Foods regulations (21 CFR 108 and 114) is Import Alert #99-38. This alert can be found on FDA’s web site at: www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the Acidified Foods regulations (21 CFR 108 and 114), juice HACCP regulation (21 CFR 120), and the current Good Manufacturing Practices regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the 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.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Robyn R. Jones, 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: Robyn.Jones@fda.hhs.gov. Please reference #432256 on any submissions and within the subject line of any emails to us. You may also contact Robyn R. Jones 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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